What are the responsibilities and job description for the QA Document Specialist position at Synergy Labs?
QA DOCUMENT SPECIALIST
SynergyLabs is an industry-leading producer of animal care products manufactured in our own 250,000 sq. ft. state-of-the-art facility in North Carolina. We distribute our bestselling brands across pet specialty, mass, food and drug, farm and feed, and digital channels with a global footprint that includes 60 countries and counting. Our merchandise lines include medicated solutions, grooming aids, stain & odor products, flea & tick controls, and nutritional supplements. For the sixth year in a row, we have been named to the Inc. 5000 as one of America’s Fastest-Growing Private Companies.
SynergyLabs is seeking to fill a position for a QA Document Specialist for its’ state-of-the-art manufacturing facility located near Hickory, North Carolina. The selected candidate will be an analytical person comfortable in establishing procedures with guidance; and will be adept at working independently.
The QA Document Specialist will be responsible for the following functions:
- Establish and manage the document control lifecycle of all QMS documents, including availability of documentation, accuracy, distribution, and periodic review
- Ensure all documentation is retained and discarded based on SOP timelines and/or customer requirements
- Authoring and modifying Standard Operating Procedures (SOP), Forms, Food Safety Plan, and Food Safety Pre-requisites for all quality and manufacturing processes with input from process owners
- Issuance, distribution, and review of controlled logbooks for all departments
- Maintain all controls required for limited access documents, labels, and chemicals through key and code logs
- Conduct training for new and revised procedures with relevant departments
- Issuance of controlled batch records and labels to manufacturing
- Review paper-based and electronic batch records for completeness, accuracy, good documentation practices, and potential non-conformances
- Perform root cause analysis for process and product non-conformances detected during reviews as needed
- Perform final approval for finished product release
- Coordinate activities as needed to support execution of CAPAs
- Assist in preparation and support tasks for customer audits and regulatory inspections
- Perform internal quality assessments to verify compliance with GMPs and procedures
- Collect and prepare monthly, quarterly, and annual quality reports
- Participate in additional quality initiatives as required
QUALIFICATIONS INCLUDE:
- Undergraduate degree or an Associate degree in Food Science, Biology, Chemistry, Quality/Regulatory
- Undergraduate degree 0-1 years experience (Associate degree 2-3 years) in Quality or related field and responsibilities preferably in the pharmaceutical, cosmetic, or food science industry
- Proficient technical writing skills required
- Must be well organized and capable of managing time-related tasks
- Working knowledge of FDA Regulations, Good Laboratory Practices and Good Manufacturing Practices
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Tuition reimbursement
- Vision insurance
Schedule:
- Monday to Friday
Work setting:
- In-person
Work Location: One location
- Health insurance