Quality Specialist

Quality Specialist

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.

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.
• 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.

You Have:

• 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.

Our Benefits (There Are More But Here Are Some Highlights):

• 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

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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