QA Operations Specialist II - Visual Inspection

QA Operations Specialist II – Visual InspectionLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.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.Location: Bedford, New HampshireDepartment: Quality AssuranceReporting To: Sr. Director, QualityShift: 1st M-F (8:30am - 5:00pm)The QA Operations Specialist II – Visual Inspection is responsible for supporting tasks and activities associated with Visual Inspection and final product sampling, packaging, storage, and shipment across the Bedford, NH site. Primarily responsible for maintaining timely product inspection such as Acceptable Quality Limits (AQL) and Bulk AQL, maintaining the final product retain program, and other tasks which support Visual Inspection from a QA and compliance perspective. The QA Operations Specialist II – Visual Inspection partners with other QA Operations functions, Manufacturing, Visual Inspection, Materials Management, and Project Management.Essential Duties and Responsibilities:Provide QA oversight and support of Visual Inspection related activitiesCoordinate with cross-functional teams to continually improve procedures with respect to visual inspection, AQL, labeling, packaging and final product release/shipments.Support scheduling activities by monitoring the production and visual inspection schedules, and communicating factors that may impact scheduled activitiesInspection of final packaged lots, bulk packaging, final product disposition functions, AQL inspection, and final product sampling and retains.Create, review, and approve final product shipper and vial labelsPerform annual inspection of final product retains, and support the maintenance of the final product retain programEnsure training and qualification status is in good standingReview of batch records and supporting GMP documentationOwnership of writing or revising Standard Operating ProceduresMaintain and evaluate current processes and procedures, and drive continuous improvement effortsMedia Fill inspectionsSupport maintenance of final product reject inventory, defect librarySupport maintenance of Visual Inspection Qualification kitsInitiation and ownership of Quality Systems such as Events, Deviations, and CAPAs.Train and/or qualify new and less experienced staff membersWork with cross-functional teams such as VI, PM, MM, and QA to schedule and appropriately prioritize activities.Support leadership in site harmonization efforts as they apply to VI and QA OperationsRepresent QA-VI on internal project teams, and other collaborative group activities such as scheduling and run readiness meetings and batch disposition meetings.Assist QA-VI team members with scheduling and prioritizing daily activities.Other duties as assigned.Qualifications:Required:High school diploma requiredStrong organizational skills and attention to detailKnowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICHKnowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks.Scientific, technical, and mechanical subject matter comprehension and aptitudeAble to articulate scientific and technical subject matterMust be able to maintain visual qualifications: (20/20 vision corrected or uncorrected checked annually); ability to see all colors and the ability to visually discern product specifications across multiple products.Ability to work in a dynamic, fast paced work environmentHonesty, integrity, respect, and courtesy with all colleaguesResilient through operational and organizational changeExceptional organizational skills and attention to detailExcellent 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:Bachelor's Degree in a relevant scientific field is a plus.Minimum 3 years' experience working in Visual Inspection, Quality Assurance, and/or Quality Control groups which support the manufacturing of pharmaceutical products highly desired.Join 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.