QA Specialist I - ACM

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. The Quality Specialist I - Aseptic Core Monitor (ACM) at PCI Pharma Services is a critical member of the aseptic operations team responsible for ensuring that all activities within the aseptic core align with regulatory expectations, PCI procedures, and industry best practices. The Quality Specialist I - ACM provides real-time oversight of aseptic behaviors during sterile manufacturing, including gowning, interventions, environmental monitoring, and material handling in ISO 5/ISO 6 environments. This role supports PCIu2019s mission of maintaining a high standard of aseptic integrity, product quality, and patient safety. ESSENTIAL DUTIES AND RESPONSIBILITIES: + Provide continuous oversight of 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. + 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. + Support media fill (aseptic process simulation) operations by providing visual monitoring and feedback throughout the process. + 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. QUALIFICATIONS: Required: + High School Diploma or GED required, Associateu2019s or Bacheloru2019s degree in Life Sciences / related field or experience in leadership role preferred. + Minimum 1u20132 yearsu2019 experience in sterile pharmaceutical manufacturing, aseptic processing, or cleanroom oversight. + Ability to learn 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. + Ability to gown for entry into ISO 5, 6 and 7 cleanroom environments and remain in those areas for extended periods. Preferred: + u200b Proficient in Microsoft Office and electronic quality systems (preferred). + Prior experience in a QA or manufacturing oversight role at PCI or a similar aseptic operation is strongly preferred. #LI-RS1 Join us and be part of building the bridge between life changing therapies and patients. Letu2019s talk future ( 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 companyu2019s 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 u2013 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._ 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 donu2019t say no, we figure out how.PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Created: 2026-03-27