Quality Specialist

About the role

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.

Key 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.
• 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.

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 , , and — 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.

Qualifications

You have a bachelor's degree in a relevant field such as pharmaceutical sciences, biochemistry, microbiology, or a related discipline. A master's degree may be considered in lieu of the bachelor's degree.

Skills

• Quality assurance and/or quality control experience
• Understanding of FDA cGMP and Section 503B of the FD&C Act
• Knowledge of USP-NF standards
• Aseptic processing experience
• Batch record review and product disposition experience
• Document control and SOP lifecycle experience
• Experience with deviation/CAPA, change control, and investigations
• Internal and regulatory audit experience
• Root cause analysis and risk assessment skills
• Technical writing and documentation skills
• Computer skills (Word, Excel, Visio, PowerPoint, Outlook)
• Familiarity with eQMS (e.g. Trackwise)
• Ability to prioritize and work independently

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