PCI Pharma Services
Overview
8 hours ago Be among the first 25 applicants Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on 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 QA Aseptic Core Monitoring (ACM) Supervisor is a key member of the aseptic operations team. This role is responsible for day-to-day supervision of the ACM associates and for performing a wide variety of semi-routine to moderately high complex activities. It ensures real-time continuous monitoring of all aseptic processing activities within the clean rooms. The ACM QA Supervisor participates in ACM training to support Contamination Control and Aseptic Governance. Responsibilities include championing the ACM Program, providing training for the ACM program, and impact assessments due to potential compromised aseptic control. Ensures compliance with applicable regulatory and industry standards, quality improvements, and safety/efficacy for phase-appropriate CGMP manufacture of drug products. Responsibilities
Lead the ACM Program and provide continuous oversight of drug product manufacturing operator performance and aseptic behavior inside the ISO 5 core and adjacent classified areas. Ensure staff observes and documents 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. Initiate quality records (deviations, CAPAs) related to aseptic governance and practices that pose potential contamination risks. Conduct root cause analysis using methodologies such as fishbone or 5 whys, etc. Capture detailed and objective records of events, interventions, and nonconformances using PCI-approved documentation tools or checklists. Track and trend data and communicate to management. Lead collaborations 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. Author and review investigations and root cause analyses for contamination events, EM excursions, and aseptic technique deviations. Provide aseptic training to existing and new personnel. May be responsible for updating training content. Author and review SOPs to support ACM and CCS as needed. Requirements
Bachelor’s Degree in a relevant scientific discipline preferred with 5-7 years of pharmaceutical or biotech industry experience and 3+ years 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). Equivalent combination of education and experience considered. ASQ certification is a plus. Exposure to RCA, technical writing, and working with quality-related investigations. Exposure to lean operation excellence highly desirable. Knowledge to apply basic scientific principles to solve operational and routine quality tasks. Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 preferred. Demonstrated ability to observe critically and document behaviors accurately and objectively. Excellent verbal and written communication skills; comfortable providing real-time coaching. Strong organizational skills and attention to detail. Proficiency in MS Office (Word and Excel). Ability to work in a dynamic, fast-paced environment. Honesty, integrity, respect and courtesy with all colleagues; creative with the ability to work with minimal supervision and independent thinking. Resilient through operational and organizational change. The base salary range for this position is $84,120.00 to $95,760.00 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. 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. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future. Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing
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8 hours ago Be among the first 25 applicants Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on 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 QA Aseptic Core Monitoring (ACM) Supervisor is a key member of the aseptic operations team. This role is responsible for day-to-day supervision of the ACM associates and for performing a wide variety of semi-routine to moderately high complex activities. It ensures real-time continuous monitoring of all aseptic processing activities within the clean rooms. The ACM QA Supervisor participates in ACM training to support Contamination Control and Aseptic Governance. Responsibilities include championing the ACM Program, providing training for the ACM program, and impact assessments due to potential compromised aseptic control. Ensures compliance with applicable regulatory and industry standards, quality improvements, and safety/efficacy for phase-appropriate CGMP manufacture of drug products. Responsibilities
Lead the ACM Program and provide continuous oversight of drug product manufacturing operator performance and aseptic behavior inside the ISO 5 core and adjacent classified areas. Ensure staff observes and documents 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. Initiate quality records (deviations, CAPAs) related to aseptic governance and practices that pose potential contamination risks. Conduct root cause analysis using methodologies such as fishbone or 5 whys, etc. Capture detailed and objective records of events, interventions, and nonconformances using PCI-approved documentation tools or checklists. Track and trend data and communicate to management. Lead collaborations 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. Author and review investigations and root cause analyses for contamination events, EM excursions, and aseptic technique deviations. Provide aseptic training to existing and new personnel. May be responsible for updating training content. Author and review SOPs to support ACM and CCS as needed. Requirements
Bachelor’s Degree in a relevant scientific discipline preferred with 5-7 years of pharmaceutical or biotech industry experience and 3+ years 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). Equivalent combination of education and experience considered. ASQ certification is a plus. Exposure to RCA, technical writing, and working with quality-related investigations. Exposure to lean operation excellence highly desirable. Knowledge to apply basic scientific principles to solve operational and routine quality tasks. Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 preferred. Demonstrated ability to observe critically and document behaviors accurately and objectively. Excellent verbal and written communication skills; comfortable providing real-time coaching. Strong organizational skills and attention to detail. Proficiency in MS Office (Word and Excel). Ability to work in a dynamic, fast-paced environment. Honesty, integrity, respect and courtesy with all colleagues; creative with the ability to work with minimal supervision and independent thinking. Resilient through operational and organizational change. The base salary range for this position is $84,120.00 to $95,760.00 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. 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. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future. Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing
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