What are the responsibilities and job description for the QA Document Specialist position at Synergy Labs?
QA Document Specialist
SynergyLabs, Inc. is an industry leading manufacturer of animal care products produced in our state-of-the-art facility in Hildebran, 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 62 countries and counting. Our merchandise lines include grooming aids, stain & odor products, flea & tick controls, and nutritional supplements. For the second year in a row, we have been nationally certified as “A Great Place To Work.”
We are a one-shift operation with 120 employees (and growing)! In addition to a rich traditional benefit package, we offer a fun work environment! Our break area includes arcade games, foosball, and cornhole. We have monthly employee lunches, Fundamental Friday winners with $500 per week in prizes, community involvement opportunities, snack days, free Yeti coffee mugs and Tervis tumblers, tuition reimbursement, fully paid maternity leave and 10 days paid paternity leave, milestone days off (marriage, new home, graduation, citizenship), and more! All in a newly renovated, bright, clean, and conditioned work environment.
SynergyLabs is seeking to fill a position as a QA Document Specialist. 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
- 2-3 years experience in Quality or related field and responsibilities specifically 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 Location: In person
Salary : $500
