Job Description
Location: Salt Lake City, UT
- Ensures compliance with established regulations and customer requirements, including GMPs as listed in 21 CFR 111 and 117 and the Global Food Safety Initiative (GFSI) scheme;
- Coordinate the product lot release schedule with customer service and lab management to ensure efficient and on-time release of product batches;
- Monitor and track non-conformances that affects Positive Product Releases (i.e. OOS, NC’s, rework, CCP failures);
- Reviews laboratory testing documents (QC Chemistry & Micro) ensuring all results conform to product specifications;
- Creation of all Certificate of Analysis, including those sent to the customer;
- Document retrieval from local files and archives, as required for submissions and customer requests. (i.e. Canada);
- Maintains deviation and change control records;
- E-File documents in quality management system and ERP system;
- Compiles all completed Batch Manufacturing Records/Filing;
- Support internal audits to ensure policies and regulations of FDA (cGMP), TDA, customer, third party certifiers and internal SOPs are followed;
- Assist with traceability and mock recall exercises;
- Assist in inter-departmental training and provide compliance guidance to personnel;
- Follow and enforce cGMP guidelines and processes as established in department SOPs;
- Perform other duties as deemed necessary.
- 1-3 years’ experience in related field preferred (quality assurance, safety, regulatory, documentation control, etc.);
- High School Diploma or GED required; some college experience preferred;
- Attention to detail, strong organization, and record-keeping skills essential;
- Effective verbal and written communication skills;
- Advanced proficiency in Microsoft Office products including Excel, PowerPoint, and Word;
- Working knowledge of JD Edwards or other inventory tracking software;
- PCQI certification preferred;
- Ability to work without direct supervision.
- Ability to lift up to 15 lbs.;
- Ability to sit and stand for extended periods of time;
- Ability to view a computer screen and type for extended hours;
- Work environment is normally in an office setting. Must be able to make frequent rounds in a warehouse environment;
- Other physical requirements include moderate standing and occasional squatting, bending, and twisting;
- Ability to wear any required PPE;
- Ability to adjust work schedule as business needs require.
- Medical, Dental, Vision
- Employer paid STD and LTD
- HSA and FSA
- Paid Maternity and Paternity Leave
- PTO
- Employer paid Basic Life Insurance
- 401(k) & Roth with employer match
- Eight Paid Holidays + 3 Floating Holidays
- Voluntary - Critical Illness, Hospital Indemnity, Accident
- Personal growth including training and development opportunities
