Job Description
Job Description
About the Role
We’re hiring a QA Supervisor to lead day-to-day quality activities in a regulated manufacturing environment (OTC, cosmetics, pharmaceuticals). You’ll supervise a small QA team, ensure release-ready batches, drive deviations/CAPA and change control, elevate technical writing quality, and project-manage cross-functional quality initiatives—while modeling excellent time management so priorities stay on track.
What You’ll Do
- Lead QA Operations: Oversee review of batch/packaging records for accuracy, completeness, data integrity, and compliance; support disposition readiness.
- Investigations & CAPA: Run investigations (5-Why/Ishikawa); write clear, defensible reports; implement and verify effective CAPAs on time.
- Change Control: Coordinate change requests (materials, process, equipment, documents) with complete impact assessments and timely closure.
- Document Control & Training: Own the lifecycle of SOPs, forms, work instructions, and quality manuals in the EDMS; assign/track role-based training.
- Technical Writing: Author/edit SOPs, investigations, risk assessments, validation docs, and training materials using plain language, consistent templates, and controlled vocabulary; maintain style guides and numbering/versioning.
- Compliance Support: Help prepare for regulatory/customer visits and internal audits; reinforce ALCOA+ data-integrity behaviors.
- Supplier/Materials Quality (as applicable): Support incoming material release, specs/CoAs, and SCARs.
- Continuous Improvement: Track QA KPIs (RFT, deviation/CAPA cycle time, training on-time, audit findings) and lead improvements.
- People Leadership: Schedule, coach, and develop QA Specialists/Doc Control staff; foster a safety-first, right-first-time culture.
- Project Management: Build and drive project plans for quality initiatives (e.g., QMS upgrades, SOP harmonization, new customer onboarding, remediation plans). Create timelines, RACI, and status reports; run stand-ups; manage risks, actions, issues, and decisions (RAID); keep stakeholders aligned; deliver on scope, schedule, and quality.
- Time Management & Prioritization: Balance multiple releases, investigations, and audits by triaging work, setting SLAs, sequencing tasks, and escalating early to protect critical path timelines.
What You Bring
- Associate’s (two-year) or Bachelor’s degree in a scientific/technical field (or equivalent experience).
- 5+ years GMP quality experience (OTC, cosmetics/ISO 22716, pharma, or related), including 2+ years supervising or leading systems/people.
- Strong knowledge of 21 CFR 210/211 (familiarity with MoCRA/ISO 22716 a plus).
- Experience supporting FDA/customer audits.
- Hands-on with investigations, CAPA, change control, batch record review, document control, and training.
- Advanced technical writing/editing (plain language, redlining, traceability, version control).
- Proven project management skills: building plans/trackers, coordinating cross-functional teams, risk management, meeting facilitation, and delivering to deadlines (experience with Asana, Jira, Smartsheet, or MS Project is a plus).
- Exceptional time management: ability to prioritize, meet SLAs, and manage multiple concurrent deliverables without sacrificing quality.
- Organized, detail-driven, and a clear communicator/coach.
Compensation & Benefits
- Salary range: Based on Experience
- Benefits: [Medical, dental, vision, PTO, holidays, etc.]
Company DescriptionInSpec Solutions, LLC is a market leading contract manufacture of topical OTC and Cosmetic Products. We are experiencing rapid growth and can offer boundless opportunities for growth.
Company Description
InSpec Solutions, LLC is a market leading contract manufacture of topical OTC and Cosmetic Products. We are experiencing rapid growth and can offer boundless opportunities for growth.