documentation specialist.

job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding 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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: Ridgefield, New Jersey
job type: Contract
salary: $25 - 30 per hour
work hours: 9 to 5
education: High School
 
responsibilities:
Documentation Management:

- Review and verify manufacturing Batch Production Records (BPRs) to ensure compliance with internal specifications, cGMP regulations, and ISO 13485 guidelines.

- Review production schedules with various departments to ensure alignment and efficiency.

- Manage the lifecycle of production documents, including creation, review, approval, and archiving.

- Manage the printing, distribution, and tracking of all production-related documentation: Batch -Production Records (BPRs), Bills of Materials (BOMs), Protocols, and Labels for production, ensuring accuracy, traceability and compliance.

- Utilize systems such as SAP and other relevant software for documentation and data management.

- Cross-functional Collaboration on documentation improvement projects to maintain integrity and compliance.

- Liaise with various teams including Quality, Regulatory Affairs, and Supply Chain to ensure seamless information flow.

 
qualifications:
- High school diploma or equivalent experience required.

Experience

- 3-5 years in a GMP manufacturing environment

- Experience in the pharmaceutical or medical device industry

Knowledge, Skills, Abilities

- Strong knowledge of cGMP regulations and ISO 13485 standards

- Proficiency in Microsoft Office suite

- Excellent organizational and communication skills

Physical Requirements / Work Environment

Work in a dynamic manufacturing environment requiring the ability to handle physical tasks such as document management and coordination with multiple departments.

 
skills: Good Manufacturing Practices (GMP), Batch Record

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.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.