{"id":3011681,"url":"https://alion.io/job/pci-pharma-services-sr-qa-operations-specialist-visual-inspection","title":"Sr. QA Operations Specialist – Visual Inspection","company":{"id":1987116,"name":"PCI Pharma Services","domain":"pci.com","url":"https://alion.io/company/pci-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":85,"open_postings":12,"ghost_share":0,"stale_share":0.583,"repost_share":0,"time_to_fill_p50_days":36,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Operations","role_family":"Operations","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bedford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":65000,"max_usd":128000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3801},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-21T15:32:47Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-11-06T05:22:33Z","board_verified":true,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"description":"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.\nWe are PCI.\nOur 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.\nPosition Title: Sr. QA Operations Specialist - Visual Inspection\nLocation: Bedford, New Hampshire\nDepartment: Quality Assurance,\nReporting To: Sr. Director, Quality\nShift: 1st M-F (8:30am - 5:00pm)\nThe Sr. QA Operations Specialist - 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 Sr. QA Operations Specialist - Visual Inspection partners with other QA Operations functions, Manufacturing, Visual Inspection, Materials Management, and Project Management.\nESSENTIAL DUTIES AND RESPONSIBILITIES:\nProvide QA oversight and support of Visual Inspection related activities\nCoordinate with cross-functional teams to continually improve procedures with respect to visual inspection, AQL, labeling, packaging and final product release/shipments.\nSupport scheduling activities by monitoring the production and visual inspection schedules, and communicating factors that may impact scheduled activities\nInspection of final packaged lots, bulk packaging, final product disposition functions, AQL inspection, and final product sampling and retains.\nCreate, review, and approve final product shipper and vial labels\nPerform annual inspection of final product retains, and support the maintenance of the final product retain program\nEnsure training and qualification status is in good standing\nReview of batch records and supporting GMP documentation\nOwnership of writing or revising Standard Operating Procedures\nMaintain and evaluate current processes and procedures, and drive continuous improvement efforts\nMedia Fill inspections\nSupport maintenance of final product reject inventory, defect library\nSupport maintenance of Visual Inspection Qualification kits\nInitiation and ownership of Quality Systems such as Events, Deviations, and CAPAs.\nTrain and/or qualify new and less experienced staff members\nWork with cross-functional teams such as VI, PM, MM, and QA to schedule and appropriately prioritize activities.\nSupport leadership in site harmonization efforts as they apply to VI and QA Operations\nRepresent QA-VI on internal project teams, and other collaborative group activities such as scheduling and run readiness meetings and batch disposition meetings.\nAssist QA-VI team members with scheduling and prioritizing daily activities.\nOther duties as assigned.\nQUALIFICATIONS:\nRequired:\nHigh school diploma required\nStrong organizational skills and attention to detail\nKnowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH\nKnowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks.\nScientific, technical, and mechanical subject matter comprehension and aptitude\nAble to articulate scientific and technical subject matter\nMust 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.\nAbility to work in a dynamic, fast paced work environment\nHonesty, integrity, respect, and courtesy with all colleagues\nResilient through operational and organizational change \nExceptional organizational skills and attention to detail\nExcellent interpersonal skills and the ability to communicate well orally and in writing\nProficiency in MS Office including Word, and Excel\nExcellent verbal and written communication skills required\nPreferred:\nBachelor’s Degree in a relevant scientific field is a plus.\nMinimum 5 years’ experience working in Visual Inspection, Quality Assurance, and/or Quality Control groups which support the manufacturing of pharmaceutical products highly desired.\nJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future\nEqual Employment Opportunity (EEO) Statement:\nPCI 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.\nAt 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. 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