Quality Control Manager - Quality

Title: Quality Control Manager

Reports to: Head of Quality

Department: Quality Control

Responsibilities:

Scheduling of QC Inspectors for Incoming Components Receiving; Raw Material Receiving Inspection, Manufacturing/Production areas, Warehouse FG auditing, Special Sample handling, Review of Inspection Records, including but not limited to: In-coming Inspection records; In-process Batch Records and related documentation.

Conduct non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups as related to QC activities.

Trains and supervises document review personnel; Incoming Inspection records, batch release personnel, issues certificates of conformance (COC), certificates of manufacture (COM), and certificates of analysis (COA) to customers on bulk and work-in-progress (WIP). Maintains accurate record of approved, quarantined, rejected products.

Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, ISO 13485:2003).

Maintain working knowledge of OTC Drug requirements for incoming materials and ingredients; components (primary and secondary); intermediates, bulk and FGs.

Reviews, Approve, Release, Quarantine or Reject per compliance inspection and testing such materials as: Incoming OTC and Cosmetic RMs; Incoming bulk and intermediates; Incoming Components; where applicable, to customer requirements.

Maintains a working knowledge of QC inspection requirements for components, raw materials, in-process/bulk and finished goods.

Ensures that review of in-process activities in Manufacturing/Production and Warehouse areas is conducted by QC inspectors for conformance to specifications; follow up on out-of-specifications including non conformances.

Participates in In-process Quality in-house and outside training program.

Conducts periodic analysis of In-process Inspection program for pre-weigh and bulk manufacture and makes recommendations.

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 & Pdn/Assembly in-process Specifications (F/As).

Reviews of batch records, fill cards, work sheets, and Inspection documentation for completeness and correctness.

Conduct non-conformance resolutions, complaint investigations, and associated corrective and preventative actions.

Reviews of QC 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 finished products, when applicable.

Perform supplier and vendor audits, as well as, Mock recall and internal audits.

Ensure compliance to Product Quality Review stipulations.

Perform the functions of Authorized Person (AP) for goods and materials.

Maintain working knowledge of QC Analytical testing including IR, pH, Refractive Index, Viscometer, Spectrophotometry, Vacuum tester, and other Instrumentation.

Maintain working knowledge of MIL-STD/ANSI/ASQ Sampling and Testing.

Maintain Standards, Range boards, and Retain Samples Program. Qualifications:

Minimum of Bachelor degree (Life Sciences, Engineering, related profession).

Five+ years industry or related experience in cosmetic, device, food, or pharma.

Previous inspecting, auditing or manufacturing experience - a plus.

Data analysis, specification development skills.

Ability to lift and carry up to 10-15 pounds.

Computer literate and effective communication skills.

Compensation & Benefits:

Pay range: $65,000 - $70,000 per year

Medical, Dental, and Vision Insurance

Life Insurance

401k match

PTO