Our client is a rapidly growing contract manufacturer of nutritional supplements, specializing in whey protein products. Known for their quality and flavor systems, they make product for everyone! We are seeking a motivated QC/QA Lab Technician. This position reports directly to the Quality Control Manager and is office-based in King of Prussia, PA.
The QC/QA Lab Technician will manage and perform all sampling, receiving document review, and all standardized and quantitative testing of raw, work-in-process and finished materials in order to ensure compliance with cGMP standards in regards to Company standard operating procedures (SOPs) and FDA regulations 21 CFR 111 for dietary supplements and any other company standard specifications.
- Follow the company quality program in accordance with customer and company requirements and specifications
- Determine, establish and enforce through all operational departments, quality and safety requirements in accordance with company needs, based on current regulatory guidelines.
- Assure that cGMP Compliance is maintained throughout all actions of production team and quality team as listed in the company standard operating procedures (SOPs).
- Assure that all documentation in regards to lab samples, retain samples, testing process and results, certificates of analysis, and customer label claims is maintained, updated, reviewed and approved for Quality Control.
- Review & Comprehend specification sheets for all components, raw materials and finished products. Assure all components and raw materials meet specifications for use in processing of intermediate (work-in-process) and final product by documented methods of sampling, testing, formulation, labeling, storage, distribution and approvals.
- Work with Production Manager to schedule appropriate times for QC Checklist during production, as well as pulling samples of Work-In Process materials. This schedule may need to adjust for each job.
- Work with Warehouse Team to schedule appropriate times for pulling QC samples of incoming Raw Materials, as well as Materials in QC Quarantine and QC Hold areas.
- Work with Finish Product Specialist to review Label claims and to schedule specific lab test to meet compliance of customer label claims.
- Assure that all process errors, product failures and any process deviations are documented, investigated and that any corrective actions and/or preventative actions are carried out timely and documented, as well as communicated to appropriate department heads.
- Report to the Quality Control Manager any regulatory issues that need to be addressed and communicate with any Regulatory Agency as required.
- When necessary, create suggestions for procedures or actions to help to build our in-house micro and analytical lab.
- Direct any and all issues in regards to lab results as compared to Specification Sheets for Raw and Finished materials to Quality Control Manager. Work together to ensure Spec Sheets match Label Claims, CoAs, and Lab Results.
- Schedule and Maintain random lab testing to challenge supplier’s Certificates of Analysis and customer’s Label Claims over and above the standard QC scheduled testing.
Knowledge, Skills, and Abilities:
- Working knowledge and understanding of current Good Manufacturing Practices (cGMP) for the Dietary Supplement Industry (FDA 21 CFR 111)
- Basic Analytical skills pertaining to manufacturing and laboratory activities
- Good verbal and written communication skills
- Personal computer literate including Internet Search, MS Word, Excel, Outlook.
- Ability to observe, monitor and keep accurate notes, during and after production & lab testing takes place.
- Strong people skills.
- Strong organizational skills
- Ability to communicate positive and negative observations to the appropriate personnel
- Ability to work alone or in a team environment
- Strong sensibility to know when to ask for help when the situation arises.