Product Documentation Specialist
Preston, CT 06365 US
- Title: Product Documentation Specialist
- Location:Preston, CT
- Industry: Pharmaceutical
- Salary: $50,000
- Employment Type: Direct Placement
401K Plan with Company Matching
Up to 3 Weeks Paid Vacation
Up to 11.5 Paid Holiday Days
Medical, Vision, and Dental Coverage
Benefits are effective the 1st day of the month following your Start Date
Client Overview: For over five decades, our client has been recognized as the world s largest and most trusted producer of Specific Pathogen Free (SPF) eggs and adjacent laboratory products and services for the development and manufacture of biologics and vaccines that are used for both human and animal health. They supply leading manufacturers with critical bioprocessing inputs, including SPF eggs, antigens, and cell products. In addition, offer numerous diagnostic testing and manufacturing support services, including virus propagation and isolation, custom cell production, and quality control testing. They also support the development of new therapeutics by providing antibodies such as IgY for use in clinical trials.
Maintain documents related to production of USDA licensed products including but not limited to Outlines of Production (OP), facility documents, labels, standard operating procedures (SOPs), batch records, and forms.
- Serve as subject matter expert for FFM and FUP USDA licensed products.
- Align SOPs, forms, and batch records with regulatory documents. Periodically audit current procedures against the OPs, SOPs, facility documents, and batch records.
- Perform periodic review and revision of regulatory documents.
- Assist with root cause analysis, corrective/preventive actions, and effectiveness checks for all licensed products.
- Assist with review of manufacturing documentation to ensure compliance with OPs, facility documents, and SOPs. Participate in hosting regulatory and customer audits.
- Conduct follow-up review and inspections of laboratory-based findings.
- Upload APHIS forms (2020, 2008) through the NCAH portal.
- Review updated APHIS regulations, memoranda, and guidance. Ensure department complies with updates.
- Identify best practices that may optimize or improve existing procedures.
Job Conditions and Physical Effort:
- Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
- Must regularly communicate with employees/customers; must be able to exchange accurate information.
- Must occasionally move about inside the office to access file cabinets, office machinery, etc.
- Associate s degree (A.A./A.S.) or equivalent in a biological science. Bachelor s degree preferred.
- 1-3 years related experience
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Must be proficient in Microsoft Office applications. Capable of writing complex information in a clear and concise manner.
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.