Quality Specialist II

Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how. 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. Job Details The Quality Specialist II, 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. 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 contamination control and environmental monitoring trending to drive site-level improvements and reduce contamination risk. Assist with investigations and root cause analysis for contamination events, EM excursions, and aseptic technique deviations. Requirements Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 2-3 years of pharmaceutical or biotech industry experience with 1+ years of experience in a QA Operations role supporting late-stage clinical and/or commercial production Understanding of aseptic techniques, contamination control, and cGMP regulations (21 CFR Parts 210/211, EU Annex 1). 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 balanced with independent thinking Resilient through operational and organizational change The base hourly range for this position is $36.64 to $41.10 plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise. Equal Employment Opportunity (EEO) Statement PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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