Quality Control Specialist II, Sterility Assurance

DIRECT HIRE

MUST HAVES:

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• 4 years of experience in a cell/gene therapy GMP environment or the pharmaceutical industry within a Quality Control Sterility Assurance role or Microbiology role
• Hand on experience running or validating at least 2 of the following microbiology rapid safety methods: endotoxin, mycoplasma, and sterility

Overview

We are seeking a highly motivated Quality Control Specialist II, Sterility Assurance. The incumbent is responsible for assisting in the development and implementation of all microbial contamination control processes/procedures for the company’s clinical and commercial programs at two manufacturing sites in Philadelphia.

This role will effectively collaborate with multiple stakeholders to ensure the harmonized execution of contamination control policies across the two manufacturing sites in Philadelphia. 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.

The Quality Control Specialist II, Sterility Assurance will have substantial experience leading QC sterility assurance program(s) in a Pharmaceutical or Biotechnology environment.

The Quality Control Specialist II, Sterility Assurance is a key support role and reports to the Manager, QC Sterility Assurance.

Essential Functions and Responsibilities:

• Assist with the development of sterility assurance principles at the site in the areas of aseptic processing, and contamination control.
• Support the site compliance to the global microbial control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, clean-room management, microbiological methods and validations, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments.
• Assist with the design of the contamination control strategy.
• Develop microbial contamination/Cross contamination risk assessments (HACCP/FMEA). Update the assessments as needed based on the changes to the program.
• Perform gap/risk assessments EM programs in response to regulatory updates (i.e., EU Annex 1)
• Develop EMPQ strategy and provides oversight of the EM testing program for regulatory compliance.
• Perform EM and Utility trending reports within deadlines, for the 2 sites in PA.
• Supports the APV strategy. Leads the microbiology related investigations for APV.
• Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial controls.
• Leads the selection and qualification of laboratory equipment for microbiological testing including Rapid Microbial Methods (RMMs). Includes procurement, budgeting, and induction process.
• Assist with alignment and harmonization regarding global microbiological/aseptic standards, policies, practices, procedures and compendial/regulatory requirements across sites.
• Participates in facility design and modification, cleaning and sanitization program.
• Participates as microbiology SME in inspections for Safety Assays and Contamination Control Programs.
• Assists with the troubleshooting contamination related issues occurring in internal and external manufacturing sites.
• Authors microbiology trend deviations, and helps trouble shoot with Microbiology safety assays related LIR, OOS, and CAPA records.
• Initiates change controls associated with safety assays Validation/verification or major EM program revisions.
• Updates EM trackers and regularly communicates to senior levels of management for issues related to contamination control.
• Assists with continuous improvement and implementing best practices (ensuring understanding/ compliance with SA related regulations and guidance.
• Performs 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.
• Authors new and revised procedures, Protocols, and reports for EM program/Safety Assays.
• Provides oversite for the microbiology personnel during safety assay validation/verification execution and compiles all the data.
• 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. Perform statical analysis of the Alert/Action levels for EM/Utility programs and update procedures as needed.
• Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.
• Perform other microbiology related studies related to media incubation, feasibility studies for sterility or mycoplasma, etc.
• SME on 2-3 of the Rapid Safety assays (Sterility via BacT, Endotoxin via EndoSafe, Mycoplasma via BioFire and/or qPCR).

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum four to Five (4-5) years of experience in the pharmaceutical industry within a Quality Control Sterility Assurance role or Microbiology role
• Knowledge and familiarity with cGMP/ICH/FDA/EU Annex 1 compliance regulations and USP, EP and JP monographs for microbiology.
• Experience with microbiological concepts and aseptic behaviors, media fills, environmental monitoring.
• Hand on experience running or validating microbiology rapid safety methods (endotoxin, mycoplasma, and sterility).
• Experience with microbiological risk assessments, trending, protocol and report generation.
• 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 leads efforts to resolve them.
• Excellent oral and written communication skills with strong technical writing experience required.
• Competent in use of Microsoft Office programs, LIMS, Visio, and/or Jump software.
• Ability to lift up to 15 pounds and stand on your feet for long periods of time.
• Ability to down gowning and work in clean rooms as well as lab setting with appropriate PPE.
• This position will require you to be on site and will be working with computer 80-90% of the time.
• Occasionally will require you to work weekends, after hours, and holidays