Will review documentation of actual process performed in the manufacture of any/all products to ensure compliance with all standard operating procedures (SOP's) and applicable regulations. Inspect all new products and determine their acceptability for release for distribution/shipment; inspect returned products to make final disposition determination. Work to resolve identified errors and deviations, review and maintain applicable equipment records, and ensure compliance with quality system standards, policies, and procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Review documentation records completed by technicians during processing of any/all products to ensure proper procedures were followed
- Identify any errors/deviations in processing records and work with appropriate individual(s) to resolve, and/or submit for review/approval as needed
- Inspect final products identified as ready for release by packaging technician to determine acceptability for distribution and shipment (e.g. product is in proper packaging, has appropriate instructions for use, correct label, untampered safety seal, etc.); compare documentation records to visual inspection of product
- Inspect condition of all returned products and determine final disposition (e.g. can it be returned to inventory, does it require re-packaging, should it be discarded as waste, etc.)
- Identify any issues with returned products (e.g. wrong quantity received, opened packaging, etc.; notify management and customer service (who processes returns)
- Review quality control records to ensure accuracy and acceptability of analytical results including product moisture levels, and out-of-specification investigation documentation, as applicable
- Make final determination of product availability (new and returned goods) for use; move product both physically and electronically (e.g. inventory database) from packaged goods quarantine room/returned product quarantine to release product storage room
- Communicate inventory levels related to newly released new product and/or returned products to fulfillment departments (i.e. operations, shipping/storage)
- Review equipment maintenance records including environmental monitoring results, preventative maintenance logs, cleaning logs, temperature logs, chart recorders, etc.
- Ensure company-wide compliance to quality system standards and procedures; identify, recommend, and assist with the development and implementation of needed improvements
EDUCATION/EXPERIENCE:
- HS Diploma or GED
- Specialized skill training; certification may be required
- 3+ years of experience in area of responsibility
- Prefer knowledge of AATB, FDA, and other state/federal regulations
SKILLS/COMPETENCIES:
- Excellent oral, written, and interpersonal communication skills
- Proficient in Microsoft Office (Excel, Word, etc.)
- Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail
- Must show aptitude to develop appropriate skills needed for the job
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)