Quality Control Analyst Job Description

Quality Control Analyst Job Description

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Quality control analyst provides direct support of all compliance requirements of CGMP standards and FDA regulations involved in the manufacturing processes of a biological product.

Quality Control Analyst Duties & Responsibilities

To write an effective quality control analyst job description, begin by listing detailed duties, responsibilities and expectations. We have included quality control analyst job description templates that you can modify and use.

Sample responsibilities for this position include:

Define quality measurements for data accuracy, completeness and timeliness
Define processes to measure quality of data maintained in the BLAW Document Management System (BDMS)
Analyze data and results for performance and trends
Help set up quality checks and test plans to ensure data quality objectives are met
Recommend enhancements to data processing workflows to improve quality of data
Provide reports on quality of data for BLAW
Provide data quality training and presentations to the BLAW organization
Provide reports on data processing trends and ways to increase efficiency
Samples from drug substance and drug product manufacturing, stability, raw materials and various protocol studies using test methods derived from the various compendia and non-compendial sources
Maintaining operational and GMP readiness of the QC areas

Quality Control Analyst Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Quality Control Analyst

List any licenses or certifications required by the position: QMS, CFCS, CFE, CFSA, CIA, CPA, ASCP, ISO9001, DOT, ACI

Education for Quality Control Analyst

Typically a job would require a certain level of education.

Employers hiring for the quality control analyst job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Chemistry, Science, Education, Biology, Biochemistry, Microbiology, Technical, Associates, Business, Life Sciences

Skills for Quality Control Analyst

Desired skills for quality control analyst include:

Word processing and spreadsheets
Basic chemical and biological safety procedures
CGMP manufacturing
EHS requirements
Applicable CTP/SOPs
Scientific methods and techniques
Incubators
Analytical equipment
FDA Regulations
JP

Desired experience for quality control analyst includes:

Participating in more complex projects, operational excellence initiatives, and various quality systems with general supervision
Plan, develop and execute CQMS to get accreditation
Investigate CPS deviations and write exception documents as required, utilizing problem-solving tools as needed to meet the corporate standard
Assist in scheduling, conducting assessment for internal processes audits and support management review
Facilitate in developing training aids to support quality training
Take lead roles ,manage and maintain SWS (Standard Work) audits & review processes for the facility

Quality Control Analyst Examples

1

Quality Control Analyst Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality control analyst. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality control analyst
  • Provide regular feedback to operations managers regarding team and individual performance based on the results of quality testing
  • Developing and implementing inspection plans, procedures and tools that effectively detect product defects
  • Providing mentorship and on-the-job training related to quality control methods, techniques and tools to the quality control workforce
  • QC incoming raw materials, in-process testing, and final QC of oligio based products
  • Work with R&D and Technical Support to transfer new products into Reagent Manufacturing and/or the Assay Design Group
  • Assist in the development of QC procedures, create and maintain QC documentation for new and existing products, processes, and equipment
  • Responsible for equipment calibration tracking
  • Assist manufacturing with filling/packaging events as requested
  • Work with Manufacturing, QA, RA, PD, and Partners
  • Review and process of project plans/authorization and financial documents associated with external QC, stability, and reference standard functions
Qualifications for quality control analyst
  • Experience communicating information in a clear, concise, data driven manner
  • Experience with Sterility or Rapid Sterility methods
  • Write Certificate of Analyses, Product Information Sheets and Stability final reports
  • Hands on experience with Risk Assessment (especially Hazard Analysis, Fault Tree Analysis, FMEA)
  • Assist with the development, revision, and implementation of departmental policies and procedures
  • Must have knowledge and experience of QC assay development, qualification, and validation
2

Quality Control Analyst Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of quality control analyst. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality control analyst
  • Perform review and approval of QC Laboratory testing and/or Analytical Services data
  • Develop new and optimize existing methods for raw materials, finished products, and cleaning validation
  • Qualify and implement new technologies and instrumentation
  • Routinely test cleaning validation, customer complaint, developmental bulk, and developmental finished product samples in accordance with specifications, policies and procedures
  • Assure that instruments used in analytical methods are calibrated and performing properly and are compliant with company data integrity policies
  • Determine composition of particles and unknowns using common laboratory techniques such as use of FTIR microscope
  • Write method validation and method transfer protocols in accordance with company policies and procedures
  • Execute method validation and method transfer protocols
  • Review laboratory documentation for compliance to applicable standard operating procedures and guidelines
  • Evaluate new analytical methods by performing required assay techniques and will modify and refine methods in accordance with change control procedures
Qualifications for quality control analyst
  • Intermediate experience with programming languages, such as Python, JAVA, VBA and/or SAS
  • Experience with non-conformance and corrective action processes is required
  • Ability to quickly learn new systems and processes is desired
  • Ability to problem solve and trouble shoot is preferred
  • Basic knowledge of SPC, quality tools, and data analysis is necessary
  • Must have desire to work independently and as part of a team in a fast paced environment
3

Quality Control Analyst Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality control analyst. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality control analyst
  • Assists with the compilation loan files for submission to investors and third party auditors for loan quality reviews
  • Assists in the development of testing for specific business practices to ensure compliance to include, with appropriate direction and understanding, the development of testing questions and protocols and implementation of the tests along with compilation and reporting results to be distributed to higher-level Quality Control Specialists
  • Evaluates and provides appropriate solutions for risk issues and presents to Senior and Executive Management
  • Oversees the preparation or prepares responses to both internal and external business audits
  • Implements processes and procedures policy controls to maintain accuracy and efficiency and reduces risk
  • Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of documentation, products, and production equipment
  • Develop and maintain project timelines pertaining to Quality Control
  • Ensure the implementation of and adherence to procedures, to ensure the safety and health of personnel working within the QC Microbiology function
  • Perform data analysis and trending of stability data in support of monitoring and method lifecycle programs
  • Takes input from leader on broad-ranging goals
Qualifications for quality control analyst
  • Read/write technical documents and build presentations
  • Possess degree preferable with Mechanical Engineering, IT or equivalent
  • Knowledge in Microsoft Office will be added advantage
  • Experience with LC/MS is required
  • Bachelor’s Degree in Real Estate, Accounting or similar industry, Attorneys preferred
  • 10+ years of commercial real estate, lease administration, or property management experience
4

Quality Control Analyst Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of quality control analyst. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality control analyst
  • Ensure the implementation of and adherence to procedures, including medical monitoring inoculations and titer testing/follow-up, and training to ensure the safety and health of personnel working within the QC Microbiology function
  • Performing gram stain and other appropriate microbial identification functions
  • Identifying and initiating deviations related to GMP operations
  • Documents production activities and experiments
  • Measure compliance and quality standards by completing data analysis and reporting
  • Conduct critical chemical and physical analyses on Raw Materials, Initial, In-process and Final products, and samples collected from environmental monitoring programs at the manufacturing facilities
  • Limited domestic travel
  • Serve as a mentor for more junior analysts within the team providing guidance and direction as needed
  • Broader understanding of other aspects of the business and apply quality principles when reviewing documentation and making decisions/ suggestions
  • Stays current on new requirements & making associated recommendations that affect area of expertise
Qualifications for quality control analyst
  • Ability to work both independently and cooperatively on project teams (both inter- and intra-Compliance)
  • Assist Product Line Managers and Engineers with processing all phases of handling returned material from initiating an RMA to providing documented corrective action to customers
  • Coordinate Evaluation and implement the disposition of returned product
  • Monitor and reporting status to customer of returned material
  • Invoice and package customer Sales Orders as required
  • Arrange, lead, and participate in RMA practical problem solving team activities
5

Quality Control Analyst Job Description

Job Description Example
Our growing company is looking for a quality control analyst. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality control analyst
  • Experience and knowledge of packaging designs, processes, materials, methods and machinery is preferred
  • Must have knowledge of FedEx package testing requirements, shipping guidelines and instructions
  • Must be able to work well alone and in a team atmosphere in order to meet tight deadlines
  • Must be organized, able to prioritize and balance multiple projects at once
  • Must be able to work full-time with the ability to put in overtime (average 50-55 hours per week)
  • Travel may be necessary (including air travel)
  • Relocation to the Eau Claire, WI area is required
  • Perform routine QC testing, including raw material, in-process, and final QC testing, stability sample testing
  • Manufacture products under ISO, USDA, and international requirements and regulations
  • Strict adherence to approved documentation and processes
Qualifications for quality control analyst
  • Must be able to take decisions under pressure
  • Must be able to read and follow all written and implied directions, policies and procedures
  • AS or BS in Chemistry or Biological Science
  • Working knowledge of the cGMP QC laboratory environment and basic equipment
  • Understanding of BOM, engineering records, component spec
  • Exposure to analytical testing equipment HPLC, GC etc

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