Senior Quality Control Resume Samples

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MN
M Nitzsche
Marjorie
Nitzsche
8454 Haskell Coves
San Francisco
CA
+1 (555) 705 7610
8454 Haskell Coves
San Francisco
CA
Phone
p +1 (555) 705 7610
Experience Experience
01/2016 present
Houston, TX
Quality Control System Support Compliance Senior Associate
Houston, TX
Quality Control System Support Compliance Senior Associate
01/2016 present
Houston, TX
Quality Control System Support Compliance Senior Associate
01/2016 present
  • Improve and develop standard operating procedures in support of QC initiatives
  • Develop and implement continuous improvement projects for the QC quality systems
  • Improve and participate in the oversight of internal quality systems
  • Analyze trends relating to discrepancy metrics and identify necessary quality adjustments
  • Design and implementation of CAPA records involving lab improvements
  • Identify compliance gaps and work towards resolution
  • Represent QC on cross-functional teams which address quality issues and system improvements
02/2013 10/2015
Boston, MA
Quality Control Senior Analyst
Boston, MA
Quality Control Senior Analyst
02/2013 10/2015
Boston, MA
Quality Control Senior Analyst
02/2013 10/2015
  • Seeks, learns, and applies new job related training and knowledge and shares knowledge with coworkers
  • To provide effective application of analytical investigations, non-conformance reporting and change management within QC as defined in SOPs
  • Leads and executes method/equipment validation, method development, and/or formulation studies and method transfers
  • To understand and follow all necessary Health & Safety systems and ensure that work is consistent with safe working practices
  • Identifies key issues in complex situations and analyzes problems and makes sound decisions
  • Develops and maintains proficiency in a broad range of test methods
  • Assist in training of other associates
06/2007 09/2012
Chicago, IL
Senior Quality Control
Chicago, IL
Senior Quality Control
06/2007 09/2012
Chicago, IL
Senior Quality Control
06/2007 09/2012
  • Also implement solution, program and outreach tests, which include phone channel testing for branching logic, prompt accuracy and quality through call simulation using our tools and business rules, as well as proper rendering and content for Email, SMS, Live Agent and Web Survey outreaches, ensuring the correct program rules are in place based on the intent of the solution and/or program
  • Identify work efficiency and process improvement and work them out with his/her manager
  • IVR, Email, SMS, Live Caller and WebSurvey content proofing to ensure the logic and all dynamic fields and values are synchronized and stated properly on specification documents at the time of content completion and approval
  • Establish and improve Quality Control for Testing processes by developing and executing test cases, scripts, plans and procedures on day to day basis
  • Assist to intent/Solutions Scope meetings
  • Collaborate with Solutions Developers and Engineering on test strategies and plans, communicating and tracking bugs/open items
  • Personal characteristics that demonstrate initiative and focus on achievement/results
Education Education
Bachelor’s Degree in Chemistry
Bachelor’s Degree in Chemistry
Kennesaw State University
Bachelor’s Degree in Chemistry
Skills Skills
  • 3 - 5 years of experience in software application testing (manual and automated) where you were responsible for testing functionality, conformance to specifications and user acceptance
  • Strong communication skills and the ability to excel in a highly collaborative and fast paced team environment
  • Strong analytical and logical thinking applied with an excellent attention to detail – thinking outside of the box
  • Demonstrated ability to multi-task with strong organizational skills
  • Ability to retain knowledge learned on the job
  • Proficient with Microsoft Office applications and expert with Microsoft Excel
  • Ability to work under pressure and meet tight deadlines
  • Personal characteristics that demonstrate initiative and focus on achievement/results
  • Previous experience in a similar position is
  • Healthcare industry exposure is
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1

Senior Quality Control Associate Resume Examples & Samples

  • Provides technical leadership through effective project management including analytical improvement projects and technical problem solving with independence. Authors, reviews, and approves (as oversight of others) controlled GMP documents, including retest protocols and reports, change control, proficient in risk assessment, regulatory standards/guidances, validation documents required to support QC business, compliance, methodology. Excellent writing, presenting and verbal communication skills
  • Participates & leads effectively in a leadership or membership role for site cross-functional teams as a representative of the QC. Leads the execution/discussions of method troubleshooting in investigational realm, IA systematic issues, improvement projects, and validation of analytical instrumentation in collaboration with the appropriate groups, across teams to meet business requirements/product disposition metrics
  • Applies holistic quality system approach through identifying and solving technical, compliance gaps and areas for improvement or remediation related to quality or process and leads through completion and sustainable implementation. Able to deliver independently, as well as provide guidance to QC team members. Global aspects considered with routine interactions across global QC
  • Responsible for coordination and execution of testing, projects, in collaboration with the laboratory operations, QC support and Analytical Technology/QA
  • LI-DEN2
  • 5 years of experience in GMP environment (QA or QC)
  • Good communication skills in Danish and English
  • Broad understanding of QC and quality, in particular within general compliance
  • Good collaboration skills in a very dynamic environment
2

Quality Control Senior Analyst Resume Examples & Samples

  • Develop and execute laboratory work plans/schedules independently, using customer milestones and department/site
  • Develop and execute complex procedures or methods with high quality
  • Recognizes and elevates changes in project scope or execution for review by project director
  • Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization
  • Advanced understanding of instrument operations and troubleshooting skills in multiple techniques
  • Propose deviations from established procedures and methods based upon sound judgment
  • Excellent written and verbal communications skills with internal and external customers
  • Can organize and manage teams chartered to address resolution of lab issues or special projects with general management guidance
  • Lead by example according to Catalent's values and culture
  • Can assess training needs and resolve gaps for less experienced team members
  • Recognize unmet department and customer needs
  • Strategy is focused on personal and team time management and efficiency
3

Senior Quality Control Engr Resume Examples & Samples

  • Analyze process/service performance using statistical methods to understand root cause, identify significant variances to predicted/targeted values and to collaborate on sustainable process improvement
  • Perform analysis of nonconformities to: characterize causes as routine (common) or exceptional (special); and develop plus implement effective containment and corrective action plans
  • Predict quality key system characteristics using historical, empirical and/or theoretical data in operational and statistical models
  • Provide Subject Matter Expertise (SME) input regarding the application of the Quality Management System (QMS), assuring quality characteristics are designed into production planning
  • Perform process analysis to identify best practices and apply lessons learned to increase effectiveness of the QMS
  • 6+ years of proven Quality Engineering/Assurance experience in a manufacturing environment. Must attest to a history of no personnel or ethical conflicts
  • Working ability and philosophy focused on core professional values of respect, trust, and team collaboration that can be demonstrated by multiple practical examples
  • Ability to work varied schedules. Candidate must be able to show evidence of being self-motivated and possess an excellent work ethic
  • Applied experience in ISO 9001 and/or AS9100 quality management systems
  • Proof of having developed and performed detailed development/production process audits
  • Must be Six Sigma certified and have ASQ training/certifications
  • Proven detailed knowledge in development/usage of Quality metrics that may be used to drive true root cause and long-term corrective action, and in the identification/institution of perceptive verifications
  • Testable proficiency in the use of pareto analysis, cause/effect diagrams, process mapping, and/or other performance analysis tools
  • Demonstrated experience in facilitating cross-functional teams in systematic improvement activities (e.g. 6-sigma, lean manufacturing)
  • Experience in Product/Process Failure Mode, Effects, & Criticality Analysis (FMECA)
  • History in manufacturing processes (assembly, inspection, and test). Understanding of sequencing for fabrication, assembly, installation, testing and other manufacturing operations relation to specific portion of the product including manufacturing line balancing
  • Demonstrated knowledge of key process characteristics and ability to implement effective process control techniques
  • Practical and applied knowledge of Additive Manufacturing, anodizing, bonding/adhesives, coating, crimping, heat treating, painting, sealing, soldering, and torqueing manufacturing processes
  • Experience in Performance Specification and Requirements Management Practices
  • Demonstrated ability to comprehend and translate external and internal requirements into effective work instructions for various internal functions. Experience in reading, understanding, and using drawings, work instructions, and written policies to guide work efforts
  • Demonstrated experience both identifying improvement opportunities as well as leading / completing process improvement projects
  • Experience with Risk Management practices
  • Testable computer skills in equipment operating systems, control systems, Corrective Action Management systems, and MS Office administrative systems
  • Knowledge and experience using SAP based production systems
  • Excellent written and verbal communication skills. The position requires a candidate that can write technical Quality documents and communicate quality needs / status to all levels of the organization in a professional and thorough manner
  • Willing to comply with all pertinent Raytheon Environmental, Health, & Safety Organizational Directives and Instructions and other applicable Program and Site Directives and Raytheon Company Policies
  • Bachelor degree in Bachelor’s degree in Engineering, Science, Mathematics, or Computer Science
4

Senior Accountant Private Equity Funds Quality Control Resume Examples & Samples

  • Contribute toward a team covering one or more client relationships
  • Deliver accurate and timely work product reviews within specified deliverables timelines, and in coordinationwith the vice president and other team members
  • Demonstrate strong knowledge of accounting, specifically with respect to alternative investment funds, with a focus on private equity, hedge funds, and/or hybrid funds
  • Review all transaction documentation and supporting files, and understand the features of the investment transactions, accruals, etc. as needed to complete quality control reviews
  • Working knowledge of liquid/illiquid investment strategies, and accounting for equity, credit/fixed income, structured finance vehicles, and derivatives instruments
  • Review work paper files for accuracy and completeness, including capital activity, investment activity, income and expense accruals, valuation adjustments, etc
  • Review management fee calculations, including offsetable amounts, management fee waiver contributions, etc
  • Review investor allocations and capital account statements
  • Review capital call and distribution calculations, sources/uses of cash, allocations, and investor notices
  • Review distribution waterfall (carried interest) models, in keeping with the applicable fund terms
  • Review financial statements, notes disclosures, and supporting schedules
  • Support SS&C corporate goals and business/departmental initiatives
  • Undergraduate degree in Accounting or related field
  • 3+ years experience in accounting, with a focus on alternative investments funds – private equity, hedge funds, and/or hybrid funds experience a plus
  • CPA designation a plus
  • Knowledge of US Generally Accepted Accounting Principles and other comprehensive basis of accounting, with an emphasis on investment partnerships
  • Experience preparing and reviewing general ledgers, work papers and financial statements
  • Deadline oriented with ability to complete assigned tasks independently
  • Attention to detail and demonstrated ability to multi-task
  • Sungard Investran experience a plus
  • Advent Geneva experience a plus
  • Proficiency in Microsoft Office suite, with advanced Excel skills
5

Quality Control Senior Analyst Resume Examples & Samples

  • Independently or with limited direction executes testing of finished dosage forms according to defined procedures
  • Participates in the self-directed work team in prioritizing, scheduling and resource allocation in order to maintain efficient workflow to assure completion of schedules
  • Ensure QC information and documentation is properly archived, tracked, trended and analyzed as needed
  • Ensure that all activities are performed according to the local Quality System and SOP’s, as well as national and local regulations
  • Demonstrate behaviours and positive attitudes in line with Quality Assurance values
  • Participates in or leads investigations of laboratory deviations and OOS results
  • Assist in the resolution of routine, and non-routine, technical problems
  • Assist in training of other associates
  • Authoring and review of SOP's and test methods
  • Participate in, or lead, QC process improvement projects
  • Review and approve data
  • Utilize all elements of the quality system to identify, classify and control the status of finished product products produced
  • To plan, prioritize, organize and execute the conduct of analytical work in accordance with the requirements of the client contract and/or technical agreement
  • To oversee projects and maintain project timelines and budget
  • To serve as Project Technical Lead
  • To ensure that safe working practices are adopted in the laboratory and comply with in-house SOP’s and other safety legislation
  • To communicate effectively with both internal and external customers, peers and supervising managers to facilitate the smooth conduct of project activities
  • To establish and maintain technical communications with other corporate groups
  • To maintain awareness of modern techniques and their application to Quality Control activities
  • To serve as technical resource for management, customers, and peers
  • Performs other duties as may be required or necessary
6

Quality Control & Mortgage Compliance Review Senior Analyst Resume Examples & Samples

  • High level of skill in Mortgage Quality Control
  • Expert in Consumer Lending and Lending regulations
  • Experience with TRID is required
  • Ability to build relationships with supervisor, peers and others
  • Speaks and writes fluently
  • Listening skills and ability to ensure open and candid two-way communication
  • Ability to expresses both facts and opinions clearly and concisely
  • Ability to work well under pressure and keep emotions under control during difficult situations
  • Adaptable and dependable in fast-paced, changing business environments
  • Strives for continuous improvement
  • Chooses the honest, ethical course of action and is consistent in word and deed
7

Senior Quality Control Lead Analyst Resume Examples & Samples

  • Supports strategies to minimize net credit losses by maximization of dollars recovered from written-off accounts (outside collection/repossession agency/attorney management). This includes assisting with on-boarding new vendors by requesting and organizing information associated with the RFP process
  • Delivers continuously improving year on year expense results by improving processes and increasing productivity
  • Builds solid peer-to-peer relationships in a team environment to meet operational needs
  • Communicates effectively and clearly on a daily, weekly, monthly basis with outside vendors to provide exceptional customer service regarding routine requests
  • Supports rigorous quality, control and compliance programs to include an ongoing control/compliance self-assessment process
  • Performs data entry, system coding, inventory audits, reconciliations, etc. to ensure alignment between vendor systems and Ally systems
  • Responds promptly to vendor requests (information, data, letter generation, etc.) on an as needed basis
  • HS diploma or equivalent required
  • 0-2 years experience in financial services or similar industry
  • Associate's degree or Bachelor's degree in business or related may be used as a proxy for the experience
  • Basic knowledge of general/standard office and administrative procedures and methods
  • Basic data entry and word processing skillsOral and written communication skills sufficient to provide routine information, greet visitors, answer inquiries, and refer calls
  • Computer skills sufficient to prepare policy manuals and enter data on spreadsheetsIn limited subject areas judgment is required to determine the applicability of guidelines or policies to specific situations
  • Some ingenuity and initiative required to collect information, coordinate activities with others, and resolve routine and/or factual problems
8

Quality Control Senior Specialist Resume Examples & Samples

  • Assist with on-site assessments for local Client Service groups (CSG). Onsite Assessments are conducted to validate CS operations are aligned to Bank procedures and any exceptions uncovered are communicated to the CS manager to provide training where necessary
  • Review Red Flag Wires and recommend release of daily high-risk wires or rejection of fraudulent wires. Wire analysis includes reviewing from a Fraud and BSA perspective
  • Work closely with the Team, Team Lead and Manager to ensure all operational issues are effectively communicated, including actively participating in ad-hoc projects and team meetings, while exhibiting ownership, follow-thru, initiative and independent judgment at all times
  • Upon request, provide unit managers accurate quality assurance status that identifies operational deficiencies. Document, present findings, and relay evaluative feedback to the unit manager and leadership
  • Review daily/periodic reports to monitor risk and ensure compliance; Reports are intended to implement quality control processes in place to validate procedures are followed by CS/PB. Analyze, monitor, and track reports for management reporting
  • Use independent judgment to determine the feasibility of the P&P in the field, advise the Manager of his/her observations, and may be tasked to suggest and revise the P&Ps, as required
  • Perform other duties and responsibilities as required or assigned by the Manager
  • Responsibilities include the following: 1) adhering to and complying with the applicable federal and state laws, regulations and guidance, including those related to Anti-money laundering (i.e. Bank Secrecy Act, US PATRIOT Act, etc.); 2) adhering to Bank policies and procedures; 3) completing required training; 4) identifying and reporting suspicious activity to the AML Officer, and 5) knowing and verifying the identity of any customer(s) that enters into a relationship with the Bank
  • Critical features of this job are described under the items above. They may be subject to change at any time due to reasonable accommodation or other reasons. This job description reflects management’s assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
  • Minimum of 2+ years of retail branch operations and customer service experience required
  • 1+ year of Audit and/or Analysis experience required
  • CFE and/or CAMS certification preferred
  • Self-starter with a high ability to quickly comprehend technical concepts, and willingness to take charge and seek out answers
  • Ability to travel to various locations throughout the United States
9

Senior Associate, / II, Quality Control Resume Examples & Samples

  • Provide technical support to to CLOs and internal virology groups functions,
  • Provide support for validation studies, and investigations, including Q-RT-PCR, Q-PCR, end point PCR, TCID50/mL, and in vitro adventitious virus assays. Review assay books in support of in process testing
  • Review and compile data for reports
  • Strong oral and written communication skills are a must
  • Knowledge of virology methods and the ability to analyze data
10

Quality Control Senior Analyst Resume Examples & Samples

  • Conducting analysis in accordance with relevant Good Manufacturing & Control Laboratory Practices
  • To lead the activities of a small team of analysts on a daily basis, ensuring effective use of resources
  • To train personnel in the used of instrumentation, software applications and new methods and procedures
  • To maintain and support the laboratory quality systems
  • Requires a Bachelor’s degree in Chemistry or related field with a minimum of 4 years full-time chemical laboratory experience or an equivalent combination of education and experience
  • Requires basic understanding of HPLC or ICP and other scientific instrumentation
  • Excellent organizational and communication skills with ability to work cross functionally
  • LIMS and/or other data systems experience a plus
  • Writing SOPs and analytical methods
  • Ability to work on own initiative in an accurate and reliable manner
11

Senior Analyst, AML Program Quality Control Resume Examples & Samples

  • Testing of Open Issues
  • Bachelor’s degree and/or post graduate experience preferred
  • Professional licenses/certifications (e.g., FINRA Series 7, CAMs, CFE) preferred
  • Minimum 1-5 years of Financial Crimes experience preferred
  • Knowledge of the brokerage industry preferred
  • Working knowledge of anti-money laundering and OFAC rules and regulations preferred
  • Strong judgment and excellent written skills with the ability to present information in differing degrees of details and form depending on the audience
  • High level of analytical and problem-solving skills
  • Strong PC skills (Microsoft Office with emphasis on Excel and PowerPoint ) required
12

Business Lending Quality Control Senior Operations Manager Resume Examples & Samples

  • Quality - Measuring quality of production teams in the United States and offshore
  • Customer - Meeting daily service level performance expectations
  • Productivity - Meeting productivity targets
  • Associate - Creating an environment with strong associate satisfaction
  • Communication - Communicating with key partners across supported lines of business
  • Risk Reduction Projects - Managing risk reduction projects
  • Measure Performance - Enhancing key metric dashboards and communication approach
  • Drive Change - Leading projects across multiple sites
  • Supporting technology initiatives
  • 1-3 years of management experience
13

Quality Control System Support Compliance Senior Associate Resume Examples & Samples

  • Develop and implement continuous improvement projects for the QC quality systems
  • Represent QC on cross-functional teams which address quality issues and system improvements
  • Improve and develop standard operating procedures in support of QC initiatives
  • Establish and track quality metrics for the laboratories
  • Analyze trends relating to discrepancy metrics and identify necessary quality adjustments
  • Facilitate closure of discrepancy records to meet on-time closure rates
  • Improve and participate in the oversight of internal quality systems
  • Design and implementation of CAPA records involving lab improvements
  • Review, assess and distribute compendial changes to all BioMarin sites
  • Identify compliance gaps and work towards resolution
  • Interface with regulatory agencies
  • Review and approve QC discrepancy records
  • Knowledgeable in global regulatory requirements and guidelines
  • Broad understanding and experience in pharmaceutical GXP
  • Experience in preparing for and participating in regulatory inspections
  • Experience with identifying issues, diving change and improvements and streamlining processes
  • Laboratory experience and/or experience with analytical methods
14

Senior for the Financial Statements Quality Control Department Resume Examples & Samples

  • Hold a degree in finance or business and possess at least 2 years’ experience in audit or Fund reporting
  • Proven accounting knowledge
  • Good knowledge of Luxembourg GAAP, other GAAPs (IFRS, US) is an advantage
  • Excellent communication skills with the ability to develop strong relationships
  • Proven analytical and organizational skills
  • Ability to work as part of a team and to coach junior staff
  • Excellent skills of Excel and Adobe PDF
  • Fluent English and French, German is an advantage
15

Senior Assistant, Quality Control Resume Examples & Samples

  • Proficient in all job processes within a functional production area
  • Performs quality audits and drives to fix problems
  • Identify defective materials, highlight failure trends/low yields and maintain test logs
  • Coordinates pilot materials order, delivery, placement and consumption for pilots
  • Performs manufacturing test on systems, and tracks and reports failures and issues to engineer
  • Identifies manufacturing trends using data
  • Applies extensive knowledge and skills to complete specialized tasks
  • Troubleshoots pilot failures at an EMR level
  • Interacts with management and engineers to resolve complex failure trends and system issues
  • May provide assistance and training to lower level team members
  • Work is completed with minimal supervision
  • Strong product build/product support experience
  • Strong knowledge of assembly processes, procedures, test process, software download and set up
  • Strong diagnostic/ troubleshooting skills
16

Quality Control Senior Supervisor Resume Examples & Samples

  • Bachelor of Science Degree in Food Science, Process Engineering, Mechanical Engineering or related field and 5 years minimum juice or beverage quality control experience
  • Clear understanding and working knowledge of Food Safety, HACCP, GMP requirements, Sanitation, and Quality Systems
  • Technical knowledge of fermentation operations, packaging equipment, pasteurization, and CIP systems
  • Highly motivated and self - directed
  • Political savvy to drive change at all levels of the organization
  • Ability to manage 3rd party auditors and certifying bodies
  • Working knowledge in principals of SPC, Project Management, Facilitation, Prioritization, Problem Solving skills
  • Ability to work in both union and non-union environments
17

Senior Quality Control Engr Resume Examples & Samples

  • 5 years quality engineering experience in a manufacturing environment
  • Ability to verify and validate assembly and test fixtures
  • Understanding of complex micro-mechanical assemblies and sub-components
  • Generate inspection and test plans for sub and final assemblies
  • Ability to read, understand, and explain to others; complex technical documents
  • Able to read and understand engineering drawings, including an understanding of GD&T
  • Capable of using Microsoft Office Suite (Word, Excel, Power Point, Visio, Access)
  • Generate and present quality metrics
  • Experience in formal RCCA
  • Able to work in a multi-company, matrix organization
  • Lean Six Sigma experience. Certification an additional plus
  • Experience with fixture design
  • Able to use CAD (AutoCAD, Solidworks, etc.)
  • Experience with micro-mechanical assembly
  • Understanding of electronics
  • Associates degree with 5 years applicable experience or BSME, BSMET with 3 years applicable experience
18

Commercial Real Estate Senior Quality Control Analyst Resume Examples & Samples

  • Identify and select sample
  • Collaborate with business to enhance or implement controls to address deficiencies
  • Provide management oversight of Quality Control Analyst and perform related duties including coaching, performance and talent management
  • Bachelor Degree or Equivalent Business Experience in Commercial Banking Portfolio Management or Loan Administration, Internal Audit, Risk Management, Quality Assurance or Quality Control
  • Ability to build positive relationships with team members across the organization
  • Ability to interact successfully with a variety of business partners across the organization including sales, underwriting, portfolio monitoring, loan administration, legal, compliance, technology and operations, to ensure risks are mitigated and compliance with relevant policies and procedures
  • Strong organizational skills with the ability to work in dynamic environment, that demands the ability to manage multiple, and often competing priorities
  • 1-3 years of supervisory or management experience
19

Corporate & Commercial Banking Senior Quality Control Analyst Resume Examples & Samples

  • Prepare and communicate monthly summary as to program status
  • Contribute to the development of quality control test scripts and related procedures
  • High proficiency with Microsoft Office Suite including Excel, PowerPoint, Word, and Visio
  • Strong oral and written communication skills and the ability to summarize and present complex information and issues succinctly for the required target audience
20

Senior Quality Control Lab Manager Resume Examples & Samples

  • Manage a team of Supervisors and Lab Analysts and be responsible to hire, lead and develop team members to ensure that the department has the appropriate talent and level of performance to meet business objectives
  • Ensure training and development of your team and building technical problem solving capabilities
  • Coach and mentor Supervisors to identify and resolve people issues
  • Assure conformance to all government and corporate regulations. Responsible to develop, provide, defend, persuade Corporate/Plant practices with outside organizations. Routinely meet with regulators (FDA & EU) and customers to ensure no interruption in business due to compliance issues
  • Meet production objectives within planned budgets, providinh input to Director for resources needed to construct budget, updates, and changes in financial plan. Manage area supplies and equipment within budgeted amounts
  • Establish and execute plans and commitments consistent to Development, Manufacturing, Customers and Business needs
  • Conceive, design, and conduct advanced independent QC activities per strategic business needs
  • Ensure research activities/projects are on track per business needs and established timeline
  • Develop, negotiate, finalize timeline and cost estimates for projects and/or service contracts to support business operations and/or external customer’s needs
  • Conceive, design, and execute projects related to the strategic needs of the business operations
  • Provide timely testing or execution of in-process, raw materials, intermediates, API, finished goods, continuous improvement initiatives, QA training, laboratory equipment validation and stability depending on area of responsibility
  • Apply advanced technical writing skills to prepare project protocol, and final reports to support product registration and/or business needs
  • Conduct business and interact/ negotiate with external contacts and customers to develop positive business relationships
  • BSc degree in Science or equivalent and 10+ years of relevant experience ORMSc degree in Science and 8+ years of relevant experience OR PhD in Science or equivalent and 6+ years of relevant experience
  • Prior experience of liasing with key regulatory bodies HPRA, FDA etc
  • Ability to make operational and business decisions with minimum direction from immediate manager
  • Must have knowledge and skill in personnel management, and develop and managing budget
21

Quality Control Senior Analyst Resume Examples & Samples

  • Performs, under minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.Works independently on assays that he/she has mastered
  • Develops and maintains proficiency in a broad range of test methods
  • Acts as a Product/Project Coordinator
  • Develops a technical understanding of each assay and assists with trouble shooting and laboratory investigations
  • Actively applies knowledge correctly in non-routine situations using a thorough understanding of the work processes and practices
  • Leads and executes method/equipment validation, method development, and/or formulation studies and method transfers
  • Identifies key issues in complex situations and analyzes problems and makes sound decisions
  • Mentors and trains other analysts, including new hires and more junior analysts, in areas of expertise
  • Maintains the laboratory in an inspection-ready state. Ensures that support for glassware cleaning and other routine laboratory functions/chores for the QC laboratory are met to meet business needs, such as lot release, method transfers, and validation studies
  • Familiars with regulations cGMP, 21CFR, USP, EP, and ICH regulatory requirements
  • Seeks, learns, and applies new job related training and knowledge and shares knowledge with coworkers
  • Interacts with other departments at BioMarin on a regular basis
  • Holds self and others responsible to abide by department and company policies and practices. Is responsible for setting a good example for more junior analysts in the department
22

Senior Quality Control Resume Examples & Samples

  • Mentor Quality Control team members
  • Train new team members within the Quality Control department
  • Identify work efficiency and process improvement and work them out with his/her manager
  • Assist to intent/Solutions Scope meetings
  • Establish and improve Quality Control for Testing processes by developing and executing test cases, scripts, plans and procedures on day to day basis
  • QA testing new tools to be released within the Solutions Operations department
  • Document testing procedures and tools
  • Troubleshooting any testing issues through black box testing methodology
  • Collaborate with Solutions Developers and Engineering on test strategies and plans, communicating and tracking bugs/open items
  • Also implement solution, program and outreach tests, which include phone channel testing for branching logic, prompt accuracy and quality through call simulation using our tools and business rules, as well as proper rendering and content for Email, SMS, Live Agent and Web Survey outreaches, ensuring the correct program rules are in place based on the intent of the solution and/or program
  • IVR, Email, SMS, Live Caller and WebSurvey content proofing to ensure the logic and all dynamic fields and values are synchronized and stated properly on specification documents at the time of content completion and approval
  • Outstanding oral and written communication skills
  • Proficient with Microsoft Office applications and expert with Microsoft Excel
  • Previous experience in a similar position is a plus
  • Healthcare industry exposure is a plus
  • Salesforce experience is a plus
  • Cloud testing experience is a plus
  • Experience with JavaScript, MySQL and HTML is a plus
  • 3 - 5 years of experience in software application testing (manual and automated) where you were responsible for testing functionality, conformance to specifications and user acceptance
  • JIRA experience is required
  • Quality Control Acceptance Test must be taken and must be able to complete one full test cycle