QA Operations Specialist I - Floor Support - C shift (Sunday-Wednesday 3:30pm-2am)

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.Position Title: QA Operations Specialist I – Floor SupportLocation: Bedford, New HampshireDepartment: Quality Assurance,Reporting To: Sr. Director, QualityResponsible For (Staff): NoThe QA Operations Specialist I – Floor Support is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial drug product in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities including observing formulation and aseptic processes, performing AQL visual inspection of finished drug product vials, GMP documentation and Batch Record review, line clear and product changeover activities, disposition of incoming raw materials, review and approval of facility work orders, and other various QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products.ESSENTIAL DUTIES AND RESPONSIBILITIES:Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time.Perform periodic walkthroughs of manufacturing and support areas to ensure adherence to policies and procedures.Batch record review for adherence to internal procedures and Good Documentation PracticesSupport the evaluation and disposition of intermediates, finish bulk drug substance and drug product.Review, approval and disposition of incoming materials such as consumables, excipients, and Active Pharmaceutical Ingredient.QA review and approval of new and revised GMP documents such as SOP’s and raw material specifications.Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.Assist in nonconforming material investigations.Review of Quality Control environmental and utility monitoring data and test resultsReview and approval of work orders impacting manufacturing facilities and utilitiesMay participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc.Advise and coach internal customers on proper documentation of tasksAssist in the initiation of Quality Systems (deviations, CAPA, Nonconformances).Perform Acceptable Quality Limit (AQL) visual inspection of final drug productSupport Visual Inspection, packaging, and labeling operationsCreate, review, and approve final product labelsPerform inspection of final product retainsParticipate in SOP revision as it pertains to process improvements.Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practicesQUALIFICATIONS:Required:Bachelor’s Degree in a relevant scientific field.Minimum 2 years’ experience in relevant GMP industry preferred.Equivalent combination of experience and education may be considered.Exposure to RCA, technical writing, and working with quality related investigations.Exposure to lean operation excellence highly desirableKnowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience workingwith international regulations such as ICHKnowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks.Knowledge and exposure to using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 preferred.Scientific, technical, and mechanical subject matter comprehension and aptitudeAble to articulate scientific and technical subject matterPreferred:ASQ certification is referred.Strong organizational skills and attention to detailAbility to make risk-based decisions and resolve issues with minimal guidance.Demonstrated positive interpersonal skills and the ability to communicate well orally and in writing.Proficiency in MS Office including Word, and ExcelAbility to work in a dynamic, fast-paced work environment.Honesty, integrity, respect and courtesy with all colleaguesAble to work with some limited supervision, able to escalate issues as needed.Is flexible and adaptable through operational and organizational change.#LI-RS1Join us and be part of building the bridge between life changing therapies and patients. Let’s talk futureEqual 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.SummaryLocation: Bedford, NH, USA; USA_NH_Bedford_25ComType: Full time