Quality Control Specialist Sterility Assurance
4 days ago
Job Summary:
The Quality Control Specialist Sterility Assurance will be responsible for ensuring the harmonized execution of contamination control policies across our manufacturing sites. This role will also support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations, and rapid microbial methods.
Key Responsibilities:
- Assist with the development of sterility assurance principles at the site in the areas of aseptic processing and contamination control.
- Support site compliance to global microbial control standards and procedures on environmental monitoring, critical utilities, contamination control strategy, clean-room management, microbiological methods, and validations.
- Assist with the design of the contamination control strategy.
- Assist with the development of microbial contamination/Cross contamination risk assessment (HACCP).
- Perform EM and Utility trending reports within deadlines for the 2 sites in PA.
- Support the APV strategy.
- Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial controls.
- Assist with the selection and qualification of laboratory equipment for microbiological testing, including Rapid Microbial Methods (RMMs).
- Assist with alignment and harmonization regarding global microbiological/aseptic standards, policies, practices, procedures, and compendial/regulatory requirements across sites.
- Participate in facility design and modification, cleaning, and sanitization program.
- Participate as microbiology SME in inspections.
- Assist with troubleshooting contamination-related issues occurring in internal and external manufacturing sites.
- Assist QC in microbiology deviations, LIR, OOS, Change controls, and CAPA records.
- Initiate change controls associated with qualification or program revisions.
- Regularly communicate to senior levels of management for issues related to contamination control.
- Assist with continuous improvement and implementing best practices, ensuring understanding and compliance with SA-related regulations and guidance.
- Perform regular GEMBA-style assessments of the aseptic process on site to assess compliance of operations, including identification of deficiencies and provide real-time coaching to aseptic staff. Perform routine audits of the manufacturing areas.
- Author new and revised procedures for Sterility Assurance department.
- Ability to work in a team environment and independently as required. May be required to work holidays and weekends.
- Ability to evaluate technical data and write technical documents.
- Advanced data integrity knowledge and practices.
- Intermediate understanding of statistics, control charts, action, and alert limits.
- Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.
Requirements:
- Bachelor's degree in a relevant discipline (biological sciences or equivalent).
- Minimum three (3) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
- Knowledge and familiarity with cGMP/ICH/FDA/EU Annex 1 compliance regulations and USP, EP, and JP monographs for microbiology.
- Knowledge of microbiological and sterility testing, media fills, environmental monitoring, microbiology methods (endotoxin, mycoplasma, and sterility).
- Experience with microbiological risk assessments.
- Successfully interface with multi-disciplined teams.
- Extremely detail-oriented with strong analytical, written, and verbal communication skills.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- High level of ownership and accountability.
- Demonstrate sense of urgency; ability to recognize time sensitivity.
- Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders.
- Flexible and adaptable style with an eagerness to take on challenges.
- Problem solver who not only identifies issues but analyzes efforts to resolve them.
- Excellent oral and written communication skills with strong technical writing experience required.
Preferred Requirements:
- Advanced degree preferred.
- Experience with cell therapy products is a plus.
Physical Demands:
- Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
- Must be able to work in a cleanroom lab setting with biohazards/ various chemicals.
- Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
- Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing up to 45 pounds.
Mental Demands:
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment:
This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.
Iovance Biotherapeutics, Inc. is an equal-opportunity employer.
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