QA Specialist I
About The Position
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of objective: The QA Specialist I, ACM is a key member of the aseptic operations team. This role is responsible for real-time continuous monitoring of all aseptic processing activities within the clean rooms. Responsibilities include continuous oversight of drug product manufacturing operator performance and aseptic behavior, ACM program documentation (including tracking and trending), and ensuring compliance of aseptic technique, gowning, and cleanroom behavior inside the ISO 5 core and adjacent classified areas. Ensures compliance with applicable regulatory and industry standards, quality improvements, and safety/efficacy for phase appropriate CGMP manufacture of drug products.
Requirements
- High School Diploma required.
- Demonstrated ability to observe critically and document behaviors accurately and objectively.
- Excellent verbal and written communication skills must be comfortable providing real-time coaching.
- Exceptional organizational skills and attention to detail
- Ability to make risk-based decisions and resolve issues with minimal guidance
- Proficiency in MS Office including Word, and Excel
- Ability to work in a dynamic, fast-paced work environment
- Honesty, integrity, respect and courtesy with all colleagues
- Creative with the ability to work with minimal supervision and balance with independent thinking
- Resilient through operational and organizational change
Nice To Haves
- Bachelor’s Degree in a relevant scientific discipline preferred.
- 1+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production in the pharmaceutical or biotech industry preferred.
- Understanding of aseptic techniques, contamination control, and cGMP regulations (21 CFR Parts 210/211, EU Annex 1).
Responsibilities
- Provide continuous oversight of drug product manufacturing operator performance and aseptic behavior inside the ISO 5 core and adjacent classified areas.
- Observe and document real-time activities during manufacturing operations, including setup, filling, environmental monitoring, sanitization and routine/corrective interventions. Includes media fill (aseptic process simulations).
- Ensure compliance with PCI aseptic technique expectations, gowning standards, and cleanroom behavior as outlined in SOPs and training.
- Identify and escalate deviations from aseptic practices, personnel behaviors, or environmental controls that pose potential contamination risks.
- Capture detailed and objective records of events, interventions, and nonconformances using PCI-approved documentation tools or checklists.
- Collaborate with Quality Assurance, Operations, Microbiology, and Training to identify opportunities for coaching, retraining, and continuous improvement.
- Participate in ACM observation trending per procedure for presentation during routine ACM program meetings.
- Assist with investigations and root cause analysis for contamination events, EM excursions, and aseptic technique deviations.
Benefits
- paid time off
- health insurance coverage (including dental and vision)
- flexible spending account
- 401(k)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
