Supervisor, QA Internal Operations

Supervisor, QA Internal OperationsLife 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: Supervisor, QA Internal OperationsLocation: Bedford, NHDepartment: Quality Assurance Internal OperationsReporting To: Senior Manager QA OperationsResponsible For (Staff): YesThe Supervisor, QA Internal Operations is responsible for leading a team of QA Operations Associates responsible for on-the-floor support (Quality in Plant or QIP) that provides 7 days a week QA oversight. This includes providing QA support in the manufacturing of clinical and commercial drug products/medical devices to ensure compliance with the principles and guidelines of cGMP. The QA Supervisor assists in assisting with quality systems, such as laboratory control, investigation management, materials management, document control and training to ensure control of the manufacturing process. This position will actively partner with Manufacturing Operations, Visual Inspection, Materials Management, and other supporting departments to provide compliance and technical guidance to ensure quality issues are identified and resolved in a timely manner.Essential Duties And ResponsibilitiesOversee and provide QA support and guidance for daily cGMP manufacturing operations.Coordinate with cross-functional teams to continually improve procedures with respect to area line clearances, labeling, packaging and material release.Support scheduling activities by monitoring the production and visual inspection schedules and reviewing factors that may impact schedules.Oversee and assist employees with product / material labeling and disposition functions, routine manufacturing area line clearances; Assist with AQL Sampling and Inspection of Final Package Lots.Review and approval of Blue Mountain documents and work ordersComplete staff performance reviews and align personnel goals to corporate initiatives.Ensure all pertinent training is assigned to staff, and employee training is in good standingAssist with review of master and executed raw material records and logbooksReview of associated QC data to support facility and productsParticipation in writing or revising Standard Operating Procedures, material control procedures, deviations, CAPA's, and Quality Investigations when applicable.Support external client audits at LSNE, and regulatory inspectionsObtain gown qualification for sterile manufacturing line clearsMaintain and evaluate current processes and procedures, and look for opportunities for continuous improvementOther duties as assignedGuide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices Assist QA Specialists in batch record reviews and generating CoAsQualificationsRequired:Bachelor's Degree in relevant scientific discipline5+ years of pharmaceutical or biotech industry experience3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production, or equivalent.ASQ certification Highly preferredExceptional organizational skills and attention to detailAbility to make risk based decisions and resolve issues with minimal guidanceExcellent interpersonal skills and the ability to communicate well orally and in writingProficiency in MS Office including Word, and ExcelExcellent verbal and written communication skills requiredPreferred:Ability to supervise and lead people in a dynamic, fast paced work environmentHonesty, integrity, respect and courtesy with all colleaguesCreative with the ability to work with minimal supervision and balanced with independent thinkingResilient through operational and organizational changeAbility to coach, train, and mentor othersEqual 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.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. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled