job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. As a family owned company, our partner's sole focus is on the products that patients utilize daily and how to improve them. In a matter of a few years, this employer has become globally recognized as a standout in the biopharmaceutical field. Helping millions of people on a daily basis, you can rest assured that the work you will do will heavily contribute to this ever-changing industry. Apply now!
location: Milford, Massachusetts
job type: Contract
salary: $19.00 - 25.75 per hour
work hours: 8 to 4
Coordinates the review and revision of procedures, specifications, and forms within the electronic records system, ensuring compliance with internal procedures. Oversight of electronic record workflows and internal archiving of GMP documents.
Administer and maintain the electronic document management system for controlled issue and retrieval of approved GMP document
o Deliver training for the electronic document management
o Manage the periodic document review process
o Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.
o Investigate and resolve user issues and system deviations
Provide assistance to site personnel to ensure documentation requirements are effectively communicated, understood and met, and that governing procedure are followed.
Support the following
o Quarterly Quality Management Reviews
o Annual Product Quality Reviews
o Regulatory Inspections
o Corporate Audits
o Other Quality Systems Support as required
Ensure compliance with all regulatory standards, systems, procedures and practices including cGMPs and other regulatory requirements as it relates to Quality Assurance activities in the manufacturing facility.
- BS in business/science or equivalent. 3+ years' experience in Quality with a GMP biotech/pharmaceutical company or other similarly regulated industry.
- Full competence with Microsoft Office, particularly Word and Excel as well as electronic document management systems.
- Strong interpersonal skills and great attention to detail are necessary.
- Must be a strong team player with good problem solving
- Good verbal and written communication skills.
- Must be able to handle multiple projects concurrently,
- Must have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
skills: MS-WORD, MS-EXCEL, Regulatory Briefing Documents, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.