Apex Systems is seeking a QC Supervisor near Webster, TX for a contract project with a global leader in pharma, biotech and consumer health . The Quality Control Supervisor ensures the QC Shared Services Department supports the release testing of drug substances and drug products in order to meet the standards for identity, strength, quality, purity, and potency. Additionally, the QC Supervisor provides focused attention on the overall function of the QC Laboratory.
RESPONSIBILITIES
Manages the day-today functions and initiatives with in the QC Laboratory
Authors and approves Standard Operating Procedures and User Requirement Specifications
Maintains all laboratory equipment ensuring the maintenance, calibrations and qualifications are performed
Maintains the material and reagent inventory within the laboratory and ensure appropriate cycle counts to re-order supplies
Provides a cleaning schedule for the laboratory
Maintains a log of all reference testing samples Performs shipment and testing of analytical samples contracted to other testing facilities
Demonstrates technical proficiency in analytical methodology: Flow Cytometry, ELISA, Cell Counting, ELISpot, PCR-based assays and Cell Culture
Executes and supports laboratory investigations, deviations, and resolves discrepancies with product testing.
Provides training and leadership to QC personnel
Ensures the Safety Data Sheets and Environmental Health and Safety trainings are up to date
Reviews all equipment logbooks and cleaning documentation
Reviews QC sample logbooks
Works closely with the Analytical Development Department to ensure the proper method transfer of qualified and validated assays to the QC Shared Services Department
Supports Facilities and Engineering and the Validation Department for all QC equipment to establish consistent maintenance, calibration and qualification schedules
Approves Material and Product Specifications, Certificates of Analysis, testing required for raw material release, Stability studies and Sampling Plans
Performs supplier selection and ensures all contract testing facilities are qualified
Provides oversight for QC personnel individual performance and goals
REQUIREMENTS
Bachelor's degree in a life sciences discipline required and 4-8 plus years of experience in the areas of the Biological Industry e.g. Quality Control and cGMP manufacturing.
2 to 4 years management experience
Proven business awareness and commercial acumen
Record of accomplishment of successfully managed projects.
Leadership skills. Motivational skills to maintain naturally high moral within the team.
Ability to communicate effectively at all levels across the organization. Has strength of character to have difficult conversations with senior stakeholders including customers, internal team members and senior management; excellent written, oral and presentation skills.
Knowledge of FDA regulations and GMP systems a plus.
Efficient, organized, results oriented and with the ability to manage multiple priorities.
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EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
