Manufacturing Documentation Coordinator

Randstad Enterprise; United States; On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Opportunity for training

Career counseling

Benefit options

Job summary

A leading staffing and consulting firm is seeking an experienced GMP Documentation Coordinator to join the Parenteral team in Durham, NC. This role involves coordinating with Quality Assurance and ensuring data accuracy in documentation. Ideal candidates will have strong attention to detail, relevant education, and experience in the pharmaceutical manufacturing industry. The position is 100% onsite, offering training and growth opportunities.

Qualifications

• 2 year or bachelor's degree preferred.
• Minimum: High School degree and 6+ months experience in a related role.
• Biowork certification and knowledge of cGMP practices are a plus.

Responsibilities

• Coordinate with Quality Assurance and Parenteral Manufacturing.
• Ensure data accuracy and compliance in documentation.
• Manage documentation and data processes.

Skills

Attention to detail

Time management

Documentation skills

Education

2 year or bachelor's degree

High School degree with 6+ months experience

Job description

Overview

Randstad Enterprises is looking for an experienced GMP Documentation Coordinator to join the Parenteral team of a Pharma manufacturing company in Durham, NC. This position comes with opportunity, training, career counseling, and benefit options. 100% onsite in RTP/Durham M-F 8am to 5pm. Contract: 1 year.

Responsibilities

• Coordinate with Quality Assurance and Parenteral Manufacturing to ensure that data generated through manufacturing activities is maintained, reviewed, corrected, analyzed and/or assessed for accuracy and compliance.
• Documentation and Data Management (80-90%): metric development; batch records; documentation reviews; compilation; quality; reconcile manufacturing materials as part of the batch record review process.
• Documentation Management: experience monitoring processes against batch records and control systems; TRNs in TrackWise (Record Number).

Who You Are

• Strong attention to detail and time management
• Effectively manage time
• Detailed with excellent documentation skills (batch records, SLRs, and logbooks)

Education and Qualifications

• 2 year or bachelor’s degree
• Minimum: HS degree and 6+ months experience
• A plus: Biowork certification and cGMP practices

Job Details

• Seniority level: Associate
• Employment type: Contract
• Job function: Quality Assurance and Manufacturing
• Industries: Pharmaceutical Manufacturing