Proclinical is seeking a Senior QC Analyst / QC Analyst II to join a leading biotech company located in Philadelphia, PA.
The Senior Quality Control Analyst supports our Cell Therapy Center quality control testing operations. The quality control testing programs include in-process and final drug product microbial testing such as bioburden, endotoxin, gram stain, environmental monitoring, and sterility techniques. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed.
Must be eligible to work in the US.
Job Responsibilities:
- Perform daily cGMP quality control laboratory microbiological testing activities.
- Perform environmental monitoring of the cleanroom areas as scheduled.
- Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
- Perform all activities for cGMP compliance.
- Support thorough cGMP investigations for out-of-specification test results.
- Support technical problem-solving.
- Support product stability programs, including execution of stability testing, stability data analysis, and final reporting of stability data.
- Operate at a consistent and exemplary efficiency level, producing high-quality and accurate results.
- Work in a cleanroom with biohazards, human blood components, and chemicals
- Must adhere to our core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Skills and Requirements:
- Bachelor's degree in a relevant discipline (biological sciences or equivalent)
- Minimum five (5) years of experience in the pharmaceutical industry within a Quality Control role
- Successfully interface with multi-disciplined teams
- Extremely detail-oriented with strong technical skills
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- High level of ownership and accountability
- Demonstrate a sense of urgency; ability to recognize time sensitivity.
- Experience with cell therapy products is a plus.
- 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.
- Must meet requirements for and be able to wear a half-face respirator.
- 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
- The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.
- 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.
If you are having difficulty in applying or if you have any questions, please contact Jessika Rodriguez at (+1) 617-391-0929 or j.rodriguez@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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