- Quality Professional/ Manufacturing/Validation Engineer highly adept at driving production, development and validation campaigns to completion for existing and new products. Diversified experience in FDA regulated industries with an extensive background in manufacturing, validation and project management. Proven success in introducing new products into the market. Creative analytical problem solver with excellent team - building skills.
- Create, review, and execute qualification protocols (IQ/OQ/PQ) and associated validation lifecycle documentation, including identification and resolution of CAPA’s and non-conformances/deviations.
- Translate system requirement specifications into executable validation protocols.
- Perform temperature mapping and other miscellaneous validation activities.
- Perform investigations and implement corrective actions related to CAPAs and deviations.
- Author, Initiate, and/or review and approve SOPs related to compliance.
Director QA Lab/Compliance
- Oversee the operation and maintenance of all testing equipment and tools in laboratory including Instrumentation for OTC drug testing.
- Enforced and monitored cGLP and cGMP compliance in the work environment.
- Managed a team of chemical and microbiology laboratory technicians.
- Assist Regulatory with questions regarding OTC, Organic Certification, NPA, NSF, CIR, EPA, Health Canada and homeopathy.
- Performed internal audits. Hosted third party audits for customers and regulatory agencies.
- Oversaw the pest control and safety programs including fire extinguisher, AED and eyewash maintenance.
- Authored and executed IQ, OQ, PQ and Process Validation for new and legacy equipment. Performed cleaning validation for tanks, fillers and ancillary equipment.
- Authored and revised SOP’s for QC, QA Lab and production.
- Maintained records and scheduled calibration for compounding, Microbiological and QA lab instruments.
- Performed safety training and SOP training for QC, Engineering and Manufacturing QA and production (pre-weigh) departments
- Reviewed and approved raw material, in process and finished goods test records, stability records, final reports and batch records.
Quality Assurance Project Engineer
- Provide support of manufacturing process validation and new product transfer to production.
- Support Product development and cross functional teams to transfer and establish product release procedures.
- Led validation, verification or qualification tasks for changes to legacy, existing and new process equipment and software to comply with 21 CFR Part 820, ISO13485 and QSR regulations.
- Performed validation for stability chambers and refrigerators using a Kaye Validator.
- Performed validation on laboratory instrumentation with software (such as Karl Fischer titrators, IR and analytical scales).
- Led value stream mapping for validation current state. Scheduled value stream future state event.
- Reviewed and approved product and process change control documentation (DCO’s, ECN’s) and specifications.
- Maintained Approved Vendor list for critical and non-critical suppliers.
- Performed as lead auditor and trained potential auditors. Performed internal and external onsite (Canada, Mexico, China, and Malaysia) supplier audits.
- Substituted for Director of Quality and Regulatory approving documents (DCO’s, validation protocols) and releasing components. Trained laboratory technicians against the department SOP’s.
- Filled in for the QC Lab Manager and releasing raw materials, in-process batches and finished goods.
- Managed CAPA system and assisted departments and suppliers resolve CAPA’s and NCMR’s.
- Interviewed, hired and managed contractors which drafted and executed protocols.
- Represented Confidential during third party (TUV Nord, FDA, UL) inspections and cGMP compliance audits. Composed and submitted responses to address audit and CAPA observations.