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Form of workJob Description
- 3-4 month contract for maternity leave coverage. Could extend/convert for the right candidate!
- ideal start date 1/8/24
- Pay Range: $28-30/hr
- 1st shift 8a-5p M-F (onsite)
- Looking for someone with 1-3 years of Documentation experience. Preferably with an FDA regulated documentation or ISO Management
Purpose of Position:
The position is responsible for maintaining quality records and operating document control systems for the site to ensure compliance with Current Good Manufacturing Practices (cGMP) and regulatory compliance as per the USFDA Title 21 Code of Federal Regulation Part 210, 211 and Guidance for Industry Q7Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Key Responsibilities:
- Manages document control systems and processes to ensure their integrity and compliance with cGMP regulations.
- Maintains master indices and tracking of standard operating procedures, deviations reports, change control reports, technical reports, protocols, batch record files, validation reports and non-conformance reports.
- Coordinates documentation activities to ensure that procedures are written, edited, reviewed and approved in a timely manner to meet established deadlines. Ensure that documentation/records are indexed, filed, archived, retrievable and issued, consistent with company procedures and policies
- Assist in the development, approval, and issuance of quality system documents.
- Assist in updating procedures specific to the Documentation Department.
- Works closely with other departments to support their documentation activities. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections
- Assist in continuous improvement initiatives.
- Strong attention to detail and self-checking skills
Required Skills/Abilities:
- The job requires a minimum of a high school diploma or equivalent and at least 1-3 years’ experience in documentation systems preferable in an FDA regulated industry.
- Must have good organizational skills.
- Solid skills with Microsoft Word, Access, and Excel.
Since 1995 Astrix has been delivering information technology consulting, regulatory advisory services and staffing solutions to the scientific community. We can assist in augmenting your internal resources to deliver optimum solutions on time and within budget. It is our goal to simply do it right. We work everyday to create value and build trust with our clients, employees, partners and vendors.
Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.
Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.
