Manager, Quality Control Microbiology (QCM)
Location: Bristol, PA
Area: Quality Control
The Manager of Quality Control Microbiology will have responsibility over QC environmental monitoring and microbiological/safety testing activities supporting GMP manufacturing. Practical knowledge in all aspects of product development from investigational phase to commercial launch. Experience working in GMP regulated environment.
This position is deputy to the Sr. Director of Quality Control/Analytical Method Development for Abzena, and supports the management of QC internal and outsourced testing, QC environmental monitoring and microbiological control programs, as well as supervises employees performing this work.
Typical Duties Include
- All duties are performed independently with minimal supervision and oversight. Incumbent is considered expert in the review process for GMP documents related to GMP facilities, test methods and processes.
- Perform review of internal and external testing data and records for drug substance in-process, release and stability testing.
- Coordinate and manage outsourced testing activities for drug substance in-process, release and stability testing.
- Evaluates test results for conformance to in-house alert/action levels or specifications and initiates appropriate corrective actions when necessary, including notification of all pertinent individuals/departments.
- Trend test results and perform out of specification investigations as required.
- Provide expertise in the review and approval of complex deviations, change controls, CAPAs, OOT/OOS thru GMP Quality Systems.
- Oversee design, implementation and management of environmental monitoring program for controlled GMP facilities and utilities.
- Initiates and investigates environmental monitoring excursions to assess any potential impact to product.
- Manages the generation, review and approval of routine environmental monitoring trend reports.
- Analyzes trend data and makes determination regarding control status of the facility.
- Recommends facility improvements and control limits as needed.
- Serve as Subject Matter Expert (SME) during audit activities.
- Follow SOPs and documents to work in accordance with cGMPs.
- Author and review GMP SOPs, qualification protocols, specifications, test methods and reports.
- Train employees on GMP procedures and applicable regulatory regulations.
- Perform additional duties as assigned.
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of Abzena’s business.
- Travels as needed to attend audits, professional conferences, and training opportunities.
- B.S. or higher degree in Biology, or related Life Sciences degree with at least 5 to 8 years of experience working under GMP and at least 3 years of managerial experience.
- Knowledge of cGMP, 21CFR, USP and other applicable regulations, standards and guidance.
- Ability to deploy quality systems within the biologics industry.
- Ability to analyze with proficiency in the application of problem solving and root cause analysis methodologies.
- Complex thinker with ability to articulate options for ambiguous situations and make decisions
- Knowledge of cGMP auditing practices.
- Ability to work well under pressure, multi-task, be organized and have effective communication skills.
- Experience in hiring and staffing a growing organization and mentoring high potential individuals.
- Demonstrate sense of urgency; ability to recognize time sensitivity
- Flexible and adaptable style with an eagerness to take on challenges
- Problem solver who not only identifies issues but leads efforts to resolve them
- Experience of working within both biologics and small molecule manufacturing Quality environments
- Knowledge of raw materials, production processes, quality control, costs and other techniques for maximizing the effective manufacture and distribution of goods
- Strong leadership and motivational capabilities