QA Auditor I

Under the direction of the QA Supervisor, the QA Auditor I will examine, question, evaluate and report to management about findings in regard to the internal quality system adequacy and deficiencies. Serve as inspectors. Initiate corrective actions as needed and verify their effectiveness. Conduct TMS, GMP and Supplier audits. Complete, review and maintain all quality related paperwork. Train on quality related procedures and roles. Perform various quality-related special projects.
Essential Functions

• Review of production records on a daily basis per GMP requirements
• Review all QC results and attached appropriate documentation to the MMR
• Conduct GMP production floor, outgoing, returns, disposals, quarantine inspections
• Partner in completing TMS, GMP, Sanitation and Supplier audits and aid in corrective action follow-up and maintenance of auditing documentation
• Verify effectiveness of corrective actions for CARs/QA/QW’s
• Review, approve and aid in maintaining COA/COC’s of incoming materials
• Assist in approvals of Raw Material Questionnaires from Vendors and Foreign Supplier Verification Program (FSVP) documentation
• Team member or Independent Reviewer of CSV team
• Assist with various quality-related special projects
• Member of FSMA hazard team
• Partner in maintaining and revising Product Labels per GMP requirements
• Maintain Raw Material Specifications and Update as needed
• Assist in completing New Product, New Raw Material, and New Supplier workflows to update QA/QC documentation as necessary

Qualifications
Education

• Bachelors degree required. Bachelor of Science degree in Biology, Microbiology, chemistry or other field preferred

Certifications/Licenses

• ASQ Certified Quality Auditor (preferred)

Experience

• 1 years (preferred)
• Quality control experience, preferably in the Food/Supplement/Pharmaceutical industry
• Experience participating in audits of internal process/production and/or external suppliers
• Experience developing and adhering to GMPs, GLPs and developing and applying SOPs

Specialized Knowledge and Skills

• Knowledge of Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Hazard Analysis of Critical Control Points (HACCP)
• Experience working with regulatory organizations, such as FDA, USDA, ISO etc.
• Previous experience developing and implementing Standard Operating Procedures (SOPs)
• Analytical problem solving/root cause analysis skills
• Proficient in Microsoft Word, Excel, Outlook
• Ability to travel internationally
• Capable of working on a team with different levels of experience and education
• Displays integrity in building relationships and a passion for the customer needs
• Works well in a team environment
• Driven to produce results for continuous improvement and cost savings
• Shows initiative to meet internal and external customer demands

Apply today and become part of the Standard Process family!
Standard Process understands the importance of diversity and believes in providing equal employment opportunity for all employees and applicants for employment. Accordingly, all personnel decisions, including but not limited to hiring, compensation, promotions, training, benefits, termination, or other terms and conditions of employment, are made without regard to age, race, creed, color, disability, veteran status, marital status, sex, national origin, ancestry, arrest or conviction record, sexual preference, genetic information, or any other legally protected characteristic in accordance with law.

Job Type: Full-time