The quality associate will be responsible for records management and customer relations to ensure conformance to Current Good Manufacturing Practices (cGMP) as it pertains to the overall quality system. The ideal candidate will be able to adhere to each relevant process in creating Master Manufacturing Records, administrating customer service, and instituting, when necessary, document control and change control using a paper-based records management system. As a part of the quality organization, the associate will participate in continuous process improvement initiatives.

- Assisting in creating new batch paperwork.

- Review Batch Production Records and all corresponding documentation for errors in Good Documentation Practices (GDP) before filing.

- Assist in training employees.

- Maintain employee training records for all functions using a paper-based filing system.

- Accurately file and maintain the latest physical and electronic copies of all company documentation in accordance with regulations.

- Verify and support Quality Technician duties, as needed.

- Assist with the revision of Standard Operating Procedures as assigned by quality.

- Provide documents needed for customer orders and registrations as needed by sales.

- Ability to identify and proactively resolve quality discrepancies.

- Answer incoming customer questions in a timely manner and aid in the investigation of customer product complaints.

- Research the safety and efficacy of various active ingredients used in the products.

- Ability to apply for government documentation needed such as USDA Dairy Certificates, FDA Free Sale Certificates for Export, etc.

- Coordinate legalization of documents with foreign embassies.

- Perform other duties as needed.

- Bachelor’s degree in the sciences or Associate’s plus 2-years’ experience is preferred.

- 1-2 years of experience working within a regulated manufacturing environment in a similar role (Document Control, Quality Systems, Compliance, etc.).

- Must possess an understanding of cGMP standards, 21 CFR Part 111, or related regulations, and how these standards apply to documentation.

- Proficiency in Microsoft Excel, Word, Outlook and/or familiarity with different types of manufacturing software (ERP, PLM, PDM, eQMS) is a plus.

- Must possess an understanding of GDP and cGMP regulations.

- Excellent written and verbal communication skills.

- Must be able to interact and build relationships with other associates and departments.

- Extremely good observational skills and a high attention to detail.

- Ability to independently organize workload to meet deadlines while working under pressure in a fast-paced environment.

Job Type: Full-time

Pay: $20.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• Assembly line
• Food Processing Plant
• In-person
• Manufacturing facility
• Office

Work Location: In person