Quality Specialist
About The Position
The Quality Specialist is an individual contributor within the site Quality Unit, supporting Quality activities in a sterile injectable cGMP / 503B environment. The role executes day-to-day quality oversight “on the floor” and within the Quality Management System (QMS) — including in-process and finished-product oversight, batch record review, environmental monitoring support, deviations and CAPA, change control, document control, and investigations — to ensure products meet identity, strength, quality, purity, and sterility-assurance requirements in alignment with 21 CFR Parts 210, 211, and 11, Section 503B of the FD&C Act, and USP standards. Working under the direction of QA management, the Quality Specialist supports release and disposition activities, identifies and escalates significant quality events, and helps sustain a state of continuous inspection readiness and a culture of compliance and continuous improvement.
Requirements
- 2+ years of experience in Quality Assurance and/or Quality Control within an FDA-regulated environment; sterile injectable cGMP or 503B outsourcing facility experience strongly preferred.
- Working knowledge of FDA cGMP (21 CFR Parts 210, 211, and 11) and Section 503B of the FD&C Act.
- Working knowledge of USP-NF standards — including <795>, <797>, and <800> — and applicable monographs.
- Aseptic processing experience and familiarity with ISO 14644, contamination control, and sterility-assurance principles.
- Hands-on experience with batch record review, in-process and finished-product inspection, and product disposition against defined specifications.
- Experience with core quality system elements — deviations/CAPA, change control, document control, and investigations — within paper and/or electronic QMS (e.g., TrackWise).
- Experience supporting internal and regulatory (e.g., FDA) audits and inspections.
- Strong foundation in root cause analysis, risk assessment, and statistical/trend analysis.
- Excellent technical writing, documentation, and verbal/written communication skills.
- Strong computer skills (Word, Excel, Visio, PowerPoint, Outlook); familiarity with eQMS (e.g. Trackwise) a plus.
- Ability to prioritize and work independently in a fast-paced environment; a highly motivated, detail-oriented self-starter.
Responsibilities
- Provide in-process and finished-product quality oversight on the manufacturing floor, including monitoring of manufacturing and aseptic processing operations for compliance with approved procedures, cGMP, and USP standards.
- Perform batch record review and support batch disposition, verifying that documentation, testing, and investigations are satisfactorily completed prior to release in accordance with approved procedures.
- Review and provide input on procedures, specifications, master/executed batch records, and controlled forms to ensure accuracy, completeness, and regulatory compliance.
- Support the environmental monitoring (EM) program, including review of data and prompt escalation of excursions and adverse trends.
- Support packaging and labeling controls, including label issuance, reconciliation, and verification to prevent mix-ups and labeling errors.
- Assist with incoming material inspection and material control — sampling, Certificate of Analysis (COA) review and acceptance, and disposition of components and raw materials.
- Support vendor/supplier quality oversight and the management of contract-laboratory testing, including sample submission, tracking, and review of results.
- Support document control and the SOP lifecycle — authoring, revision, routing, and periodic review of GMP documentation — and maintain a current, compliant, audit-ready repository.
- Initiate, support, and document deviations, OOS, and CAPAs, including investigation, root cause analysis, and verification of effectiveness.
- Support quality system programs including, change control, document control, training, complaints, quality event management, etc. and the implementation of Trackwise eQMS.
- May serve as a process owner for an element of the quality system, based on experience and background.
- Support risk management and assessment activities for assigned areas.
- Participate in internal and external (third-party and regulatory) audits and help maintain continuous inspection readiness.
- Support preparation of the Annual Product Quality Review (APQR) through data compilation and trending.
Benefits
- Competitive salary & equity compensation for full-time roles
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
- Offsite team retreats
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
