Quality Assurance Manager, Head
Job Locations US-MD-Silver Spring
# of Openings : 1
Type : Regular Full-Time
CAMRIS International is an medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.
CAMRIS is seeking a Quality Assurance Manager who will provide leadership and accurate information based on current Good Manufacturing Practices (cGMP) and other governing regulatory documentation to Pilot Bioproduction Facility staff.
*This is a forecasted position and it is contingent upon contract award.
Direct work and manages the Quality Assurance, Inventory and Calibration staff.
Make continuous improvements to the Pilot Bioproduction Facility (PBF) and Quality Systems to execute and implement cGMP and increase system efficiency.
Design (if required) and implement the following cGMP systems: Internal Training, Deviation, Failure Investigation, Critical Change Control, Corrective Action, Internal Auditing, and External Auditing.
Coordinate the following programs: calibration, inventory, documentation, preventative maintenance, equipment, validation and cleaning.
Provide guidance and training to all Biologics staff and Principal Investigators on compliance (cGMPs) and Quality Systems.
Direct the work of all outside contractors performing work for the Quality Assurance (QA) Dept and as directed by the Dept Chief.
Assist with supplying regulatory information (IND submissions, etc.) as directed by the Dept Chief.
Support Principal Investigators and CRADA Partners as required with compliance and regulatory concerns.
Provide back-up support to Dept Chief and coordinates to meet the facility quality goals.
Provide assistance to all Facility Section Heads on cGMP issues. Note: the Dept Chief, as required, will assign other duties.
Write, review, and edit Batch Production Records (BPRs), Validation Reports, Protocols, Forms, and Standard Operating Procedures (SOPs). Has signature authority for disposition of final and in-process products; has review and signature authority for Product Certificates of Analysis. Interfaces with Program Manager, Human Resources (HR), Payroll Dept Chief, etc. to provide information to staff and address staff concerns.
Provide assistance with review and resolution of deviations, failure investigations, and critical change and validation documents.
Collect, review, rectify, and trend data (QC, Calibration, Water, BPR, Environmental, etc.).
Perform, train, and direct QA staff to perform internal and external audits as well as assist in correcting audit deficiencies.
Manage the updating of all documentation and tracking information periodically (spreadsheets, database, logs, etc.).
Assist in resolving, documenting and performing corrective actions for failures that occur at or are related to the PBF, including facility repairs, utilities, equipment and instruments.
Train QA staff on cGMPs and Quality Systems. Verify labels as required.
Interact with building monitoring system to ensure equipment remains in proper state of operation.
Notify Section Heads if production equipment fails.
Provide service to Production Personnel, CRADA partners, and Principal Investigators to ensure their quality compliance needs are met.
Assist Department Chief with budgeting for the QA section.
Back up other QA staff members as needed.
A BS/BA degree in Biology or related field.
At least six years employment at a Biotechnology, Pharmaceutical or related facility.
At least four years’ experience in QA in the areas of documentation control, raw material management, instrument calibration, validation, repair, facility system controls, internal and external audit competency and compliance training expertise.
Experience in GMP production and cGMP/GLP.
Must have GMP and regulatory training and a full understanding of inventory control or material management from a Biotechnology, Pharmaceutical or related facility.
Familiarity with Microsoft Excel
0 and Access 2000 (or higher versions).
Ability to follow directions, written policies, and procedures for all work responsibilities.
All proposed personnel to perform services contractor must verify employment eligibility (E-Verify) and obtain a favorable National Agency Check (NACI).