Senior Quality Control Job Description

Senior Quality Control Job Description

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Senior quality control provides direct supervision of QC analysts performing routine GMP testing of potency, bioassay, ELISA and related methods, assuming primary responsibility for communication of requirements and expectations of the employee’s daily job.

Senior Quality Control Duties & Responsibilities

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

Sample responsibilities for this position include:

Leads the Quality team to produce precise, accurate and timely test and calibration data
Develops and implements new Quality procedures as needed
Provides technical support including root cause investigation of product failures and analytical service requests from technicians
Drives continuous improvements
Develops annual budgets and operating plans to support the programs
Ensures proper documenting of program activities
Conduct comprehensive reviews of complex and highly confidential cases to ensure the appropriate decisions, recommendations and referrals to law enforcement have been made according to department standards and that appropriate documentation has been obtained
Identify inaccuracies and/or incomplete work
Identify issues and efficiencies and proactively make recommendations for change and process improvements
Review SARs to ensure they meet regulatory requirements

Senior Quality Control Qualifications

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

Licensing or Certifications for Senior Quality Control

List any licenses or certifications required by the position: ISO, III, CAMS, IPC, II, CCRC, CCRP, CCRA, CPA, TC

Education for Senior Quality Control

Typically a job would require a certain level of education.

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

Skills for Senior Quality Control

Desired skills for senior quality control include:

DOE
FMEA
MSA
QMS and other problem solving techniques
CGMP
ELISA
GMP
Cell culture and aseptic technique
GMP requirements
General chemical and bioanalytical test methods

Desired experience for senior quality control includes:

Privacy certification (e.g., CIPP)
Bachelor’s degree in Biology, Chemistry or related discipline preferred
3-5 years of related quality assurance experience and/or airline domain experience
Team player and highly collaborative person
Will provide oversight of multiple strategic, enterprise technology vendor relationships across the organization (large to smaller vendors)
Oversees risks in alignment with the Enterprise Risk Framework (ERF)

Senior Quality Control Examples

1

Senior Quality Control Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of senior quality control. 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 senior quality control
  • Provide training, coaching and direction to FIU, BSA/AML and Line of Business staff
  • Ensure a high level of quality work that meets internal and regulatory deadlines
  • Distribute, allocate, assign, and disseminate tasking for the review of individuals from selected Army programs
  • Manages day-to-day operations within the assigned functional group to ensure materials and products are tested, reviewed and approved within the accepted time frames
  • Reviews, authors, and edits documents, including deviations, change control requests, SOPs, test methods, and laboratory test plans and related technical reports
  • Provides leadership for managers, analysts and technicians to optimize productivity and quality of work
  • Actively participates on cross functional teams (may include facilitation) and shares information, as appropriate, with direct reports
  • Implements procedures and optimal infrastructure to ensure compliance with all regulatory agencies
  • Provide training and ensure adequate proficiency of QCRM staff with respect to analytical methods principle and critical parameters
  • Conducts quality assurance reviews of clinical research studies
Qualifications for senior quality control
  • Ability to rapidly learn new skills and expand expertise into other areas
  • 2 or more years’ experience in supervisory or team lead position of 5 or more personnel with the FBI or a military service
  • Qualified candidates must have a current TS/SCI Security Clearance and must be willing to complete a CI Poly
  • Relevant scientific degree with minimum 7 years related experience in bio-pharma analytical laboratory
  • Experience with viral vector (adeno-associated virus) product is a plus
  • The Quality Control Microbiology Supervisor/Sr
2

Senior Quality Control Job Description

Job Description Example
Our company is looking for a senior quality control. 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 senior quality control
  • Assists in preparing for outside audits and monitoring visits
  • Assists in training clinical research staff and investigators
  • Tracks activities of the quality assurance program
  • Includes some US travel
  • 1-2 years of related analysis or an appropriate combination of education and experience
  • Strong attention to detail, yet maintain a big-picture point of view
  • Actively monitor results for SLA, trending patterns and/or issues that impacts NIAT and report them for corrective actions
  • Actively contributes to the success of the underwriting team by ensuring that processes and procedures are followed in timely manner and initiatives that impact NIAT
  • Perform various oversight requirements as outlined within related procedures
  • Ensure that all activities are performed according to the local Quality System and SOP’s, national and local regulations
Qualifications for senior quality control
  • Experience in a CPA firm performing audits of not-for-profit clients and/or QC of not-for-profit client audits
  • Knowledge of consumer related banking laws and regulations and understanding of the financial services industry, including Basel and Unfair or Deceptive or Abusive Acts o Practices (UDAAP)
  • A minimum of 15 years of relevant experience (A.S
  • Technical knowledge regarding Microbiology testing methodology
  • Relevant experience in Environmental & Utility Monitoring program design and rapid microbial technology are preferred
  • Requires a minimum of a Bachelor's Degree in Chemistry, Biology, Biochemistry or closely related discipline and a minimum of eight (8) years in a laboratory environment including at least six (6) years’ experience with analytical equipment and four (4) years’ experience with cGXP or other regulations (DEA, EPA, DEQ), or equivalent
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Senior Quality Control Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of senior quality control. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior quality control
  • Serves as Quality Management Representative
  • Drives regulatory strategy and activities to secure and maintain regulated class II devices and 510K and CE products
  • Serves as head of the Safety Committee (MN)
  • Assesses impact of regulatory environment on existing and future products
  • Anticipates regulatory and quality requirements for product portfolio
  • Quality Management System monitoring, maintenance and improvement
  • Ensures regulatory and quality compliance of products and facility
  • Implements continuous quality improvement processes
  • Identifies company-wide quality metrics
  • Provides regulatory inputs to risk analysis process
Qualifications for senior quality control
  • Knowledge of SAP and LIMS desired
  • Strong technical background in compendia! testing and related equipment, including wet chemistry identify, IR & UV spectroscopy, Karl Fischer, Gas Chromatography and ICP are preferred
  • Bachelor's degree from an accredited University in Business, Industrial Engineering or related field
  • Completes AS400 and Analyst Guidance Exception report reviews
  • Completes controls developed to support Underwriting
  • Must thrive in a fast paced environment and comfortable with changing priorities
4

Senior Quality Control Job Description

Job Description Example
Our growing company is hiring for a senior quality control. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior quality control
  • Manages external and internal audits
  • Oversees CMO drug substance testing and stability studies
  • Provides the overall strategy for the design, execution and support of stability studies for intermediates, drug substance and commercial drug/device combination products
  • Supports stability study designs to address process changes, material changes, and comparability studies due to capacity expansion or process scale up
  • Defines and drives the strategy for computerized system implementation for stability and sample management, testing, and data tracking for inventory of reference standard and control materials
  • Responsible for implementing and completing necessary statistical tools for stability data analyses and trending
  • Escalates, as needed, to QC and QA Executive Directors in event of unexpected and OOS stability events
  • Defines strategy and ensures sound scientific rationales for the implementation of method reference standards and associated stability programs in alignment with pharmacopeias and regulatory requirements
  • Drives initiatives to enhance standards and controls programs and performance and trending methodologies
  • Provides guidance and training to commercial QC representatives on various projects and CMO oversight and ensures meeting key milestones
Qualifications for senior quality control
  • Minimum 5 years of insurance
  • Extensive knowledge of residential lending practices and procedures and compliance regulations
  • Thorough knowledge of mortgage underwriting procedures, policies, guidelines and regulations
  • Thorough knowledge of credit, income and asset analysis and property review and valuation requirements
  • Thorough underwriting knowledge of mortgage investor’s guidelines to include
  • Understanding of processing, underwriting and closing procedures
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Senior Quality Control Job Description

Job Description Example
Our company is hiring for a senior quality control. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior quality control
  • Partners and aligns with development and rest of commercial QC organization on content of submissions
  • Collaborates with stakeholders to resolve issues and define escalation mechanisms
  • Partners with internal stakeholders and external partners to support company objectives and ensure that the team meets quality, regulatory and compliance requirements
  • Provides effective leadership including, individual goal setting/performance reviews, managing the development of employees, selecting personnel and motivating members and supporting diversity and quality
  • Lab Tech will be validated and qualified to perform Salmonella and other extraneous pathogens testing, hemagglutination and potency/identity testing of TS-11 final products
  • Backup technician for other government regulated testing including but not limited to Mycoplasma, Raw materials, and Extraneous Pathogens testing
  • Reviews departmental documentation (e.g., Standard Operating Procedures)
  • Lab Tech will be validated and qualified to perform extraneous pathogens and mycoplasma testing
  • Assist with other extraneous virus testing and bacterial as needed
  • Backup technician for other government regulated testing including but not limited to Salmonella testing and Hemagglutination testing
Qualifications for senior quality control
  • Minimum of 3-5 years of experience working as an underwriter
  • Knowledge of Quality Control Guidelines
  • Ability to apply sound credit risk principals and practices in making QC review decisions
  • Excellent interpersonal skills including oral and written communication skills and customer relations skills with leadership ability
  • Good organizational skills with the ability to handle multiple tasks simultaneously in a competent and professional manner
  • Ability to discern misrepresentation and fraud

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