QC Manager

Job Summary:

With assistance and direction from Senior Management, the QC Manager will be responsible for the development, implementation, maintenance and performance of both internal and external quality control activities, as well as scheduling the performance of or performing routine and non-routine analysis of raw materials, in process, and finished product according to SOPs. This person may perform special projects or analytical and instrument problem solving; apply knowledge of GMP and GLP; and support all applicable regulations including FDA and ISO requirements.  The QC Manager will recommend and implement corrective actions necessary to ensure consistent adherence to the organization’s quality program.  Responsible for direct reports as required.

Responsibilities & Duties:

• Plans, coordinates, directs and performs required activities in the area of a quality control program designed to ensure continuous production and release of clinical products consistent with established standards and procedures.
• Designs and implements appropriate product stability protocols to asses both short term and long term stability
• Analyzes statistical data and approves testing methods requiring testing qualification and validation studies.
• Reviews and analysis product specification trends to determine reasonable product release specifications to insure product consistency of the finished product.
• Formulates and maintains quality control objectives and coordinates objectives with Assay Development, QA and Manufacturing staff to maximize product reliability and process efficiency.
• Plans, promotes, and organizes training activities related to product quality and reliability.
• Schedules the performance of internal and external routine and non-routine analysis of raw materials, in process, and finished product formulations according to standard operating procedures.
• Compiles data for documentation of test procedures and prepares reports.
• Ensures the calibration and maintenance of laboratory equipment (may also develop testing methods).
• Reviews data obtained for compliance to specifications and reports abnormalities.
• Revises and updates Standard Operating Procedures (SOPs) as needed. Writes validation protocols, QC deviations and reports for analysis methods.
• Reviews and approves instrument validation protocols.  Directs or performs OSS investigations when required.
• May perform special projects or analytical and instrument problem solving.
• Applies knowledge of good manufacturing practices (GMP's),good laboratory practices (GLP's) and has a good working knowledge of FDA regulations and ICH Guidelines.
• Trains QC technicians in the performance of product testing procedures. 
• Reviews and approves QC technician data for completeness, legibility, and accuracy ensuring that established procedures were followed and that all data is present, accurate and reviewed in accordance with release criteria.
• Responsible for managing the transfer of assays for lot release from assay development to Quality Control.
• Complies with company safety policies and minimizes risk to self, others and the environment, consistent with the community and industry standards.
• Actively pursues corporate timelines and milestones set by the department director and upper management.

Requirements:

• Requires a Bachelors, Masters or PhD. degree in a scientific discipline (Biochemistry, Microbiology, etc…), with minimum of 3-5 years of QC or QA laboratory supervisor experience.
• Previous experience with whole cell vaccines and small test volumes preferred.
• Minimum 5 years work experience in a biopharmaceutical GMP environment, resulting in a comprehensive understanding of statistics and user requirements with respect to current established USP testing methods and support systems.
• The ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures or governmental regulations is required.
• The ability to write reports, business correspondence and procedure manuals; ability to communicate effectively the status of QC testing of materials produced as applicable to the planning/inventory schedule (MPS);
• Ability to apply advanced mathematical concepts such as exponents and logarithms; and the ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis is essential.
• Must be able to think strategically, negotiate and influence effectively, understand complex technical issues and be able to translate and communicate them clearly to less technical personnel. Strong collaboration, team building, and people development skills a necessity.