Quality Assurance Associate
4 weeks ago
This is a high-regulatory-responsibility position that provides direct quality oversight for the cGMP production of Dietary Supplements and nutraceuticals.
The ideal candidate will ensure compliance to SOPs, batch records, master manufacturing records, and to 21 CFR Part 110 and 111.
Key Responsibilities- Understand and assist in maintaining compliance to FDA Regulations 21 CFR 110 and 111 for food and dietary supplements and other global food regulations as needed.
- Execute the batch disposition process for raw materials, components, and finished products.
- Lead investigations for quality-related issues through non-conformance and deviation systems, CAPA process.
- Interpret and implement quality assurance standards/SOPs effectively and accurately.
- Mentor the Quality Specialist performing batch record review process.
- Assist and/or lead internal audits and regulatory audits as directed by management.
- Assist with equipment qualification and process validation as needed.
- Provide oversight to the calibration process.
- Provide oversight of the change control process.
- Perform complaint investigations.
- Gather, trend, and assess data and maintain metrics for Quality Assurance.
- Train, support, and mentor QC Inspectors that assist in providing direct production oversight.
- Other projects as directed by the QA Manager.
- Meets all safety expectations and follows all safety practices.
- Works extended hours and occasional weekend overtime.
- Other duties as assigned
- Minimum of 3+ years of experience in a QA Inspector within a nutritional supplement, food, consumer products or pharmaceutical company.
- BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus.
- Demonstrates ability to work in a team and assist others.
- Able to follow written instructions precisely and perform basic math calculations as required.
- Attention to detail and accuracy with numbers.
- Understands and is knowledgeable of cGMP, OSHA standards etc.
- Must be able to distinguish different shades of colors.
- PC-based computing experience (Word, Excel)
Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise and fumes.
The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents.
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