Experience: The ideal applicant should have previous QA experience in preparing and maintaining Quality policies and procedures along with the ability to spot errors. Practical experience with QA support of manufacturing.
Department: Quality & Compliance
Primary Job Duties & Responsibilities:
· Develop, implement, and maintain QA policies, procedures, and guidelines for OTC and cosmetic manufacturing and packaging operations in compliance with industries regulations and standards, such as FDA 21 CFR 210-211, EU Cosmetic Regulation (EC) No 1223/ 2009, GMP, and ISO 9001/ISO 22716 (Cosmetic GMP)
· Review and approve SOPs, validation protocols, and other quality or technical documents to ensure accuracy and compliance with regulatory requirements and industry best practices
· Evaluate and manage suppliers to ensure their compliance with quality and regulatory requirements
· Interact with 3rd party laboratories in tracking sample submissions and test results
· Lead root cause analysis investigations and implement CAPA
· Manage the CAPA program, ensuring timely investigation, resolution, and closure of identified issues, including effectiveness checks.
· Monitor, analyze and report on quality metrics to identify trends, areas of improvement and CAPA.
· Prepare and maintain change control, OOS, deviation investigation reports and Mock Recalls
· Review and approve change control requests, ensuring that proposed changes are evaluated for their impact on product quality and regulatory compliance
· Issue and maintain R&D notebooks and manufacturing related logbooks
· Conduct routine quality internal audits and inspections to ensure adherence to SOPs, GMPs, and other relevant guidelines.
· Support external audits and inspections by regulatory authorities and customers and assist with the implementation of any required corrective actions
· Ensure manufacturing and analytical equipment is appropriately maintained and calibrated.
· Participate as an active member of Compliance team ensuring successful establishment and implementation of ISO 9001/ISO 22716 (Cosmetic GMP)
· Other tasks as required
Skills & Qualifications:
· Good technical writing skills
- High attention to detail and excellent organizational skills are critical
- Must have the ability to prioritize, manage time well, multitask, and troubleshoot
· Ability to work independently with minimal supervision.
- Knowledge of cGMP requirements (including MoCRA) is required.
- Prior experience with a paper-based QMS is a plus.
- Strong knowledge of Microsoft Word, Excel and Acrobat (PDF) documentation systems.
- HS Diploma with min. 5 years’ experience in QA/QC (or bachelor’s degree with 2-5 years’ experience)
Job Type: Full-time
Pay: $65,000.00 - $75,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Experience level:
Schedule:
Work setting:
- In-person
- Manufacturing facility
- Office
Work Location: In person