Quality Assurance (QA) Lead- Documentation and Product Release - (Quality)

Title: Quality Assurance (QA) Lead- Documentation and Product Release

Reports to: Quality Assurance Supervisor or Manager

Department: Quality Assurance

Responsibilities:

• Support Annual Drug and Device History Reviews.
• Oversee and maintain the Quality modules in the ERP system for compliance (Change Controls, Deviations, Discrepant Materials, Returns, Supplier Issues, etc.
• Support Investigations (e.g. non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups).
• Lead the review, release of compliance materials (eg FG, RM, bulk and intermediates as required to support customer requirements). Also maintain accurate record of approved, quarantined, rejected materials and products.
• Support audits, inspections and ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, TGA, OSHA, MFDS, ISO 22716; ISO 13485:2016).
• Maintains a working knowledge of QA inspection requirements for components, raw materials, in-process/bulk and finished goods.
• Participates in In-process Quality in-house and outside training program.
• Assist in interpreting and/or developing of customer specifications and requirements for approved formulas.
• Assists in establishing production and assembly inspection information sheets and documentation as required.
• Maintains and updates ERP System, maintains repository of batch records/documents, and other Mfg & Assembly in-process Specifications.
• Reviews of batch records, work sheets, and Inspection documentation for completeness and correctness.
• Support non-conformance resolutions, complaint investigations, and associated corrective and preventative actions.
• Reviews of QA Inspection reports daily for correctness and completeness.
• Facilitates on site customer inspections, coordinating availability of product and communication of disposition to Quality and Inventory Control. Interfaces with customer distribution operations where needed.
• Maintains awareness and compliance with safety regulations in performing job duties.
• Ensure that finished goods, bulk, raw materials, components are maintained correctly in the warehouse and other holding areas.
• Assist in the review and release of bulk and finished products.
• Support Process Validation and Cleaning & Sanitization Validation activities under the quality systems to ensure compliance.
• Support formal drug stability program, bulk hold studies, and product compatibility by co-ordinating samples submission, testing, result retrieval and program review.
• Maintains files and database of customer-approvals and documents as evidence of authenticity.
• Effects changes to specification sheets as approved through proper change control requests.
• Support Change Control Requests for Customer requested changes to raw material, intermediate/bulk, FGs, specifications.
• Maintains copies of approved change controls as applicable to product specification updates/revisions.

• Minimum of associate degree or bachelor degree (Life Sciences, Engrg, related profession).
• Three + years industry or related experience in cosmetic, device, food, or pharma.
• Previous inspecting, auditing or manufacturing experience - a plus.
• Data analysis, specification development skills.
• Computer literate and effective communication skills.

• Medical, Dental, and Vision Insurance
• Life Insurance
• 401k match