What are the responsibilities and job description for the Quality Assurance Associate - Document Control/Plant QA position at Recruits Lab?
Job Title: Quality Assurance Associate - Document Control/Plant QA
Location: Paris, KY
Duration: 6-month contract (Full-Time)
Shift: Night Shift, 12-hour shifts (3 on, 2 off, 2 on, 3 off)
About the Opportunity:
Our client, a leader in the biopharmaceutical industry, is looking for a Quality Assurance Associate to join their team in Paris, KY. This is a contract role that will focus on document control and plant quality assurance activities within a regulated manufacturing environment. The position is ideal for someone with a background in quality assurance and GMP (Good Manufacturing Practices), looking to contribute to operational excellence in the pharmaceutical manufacturing process.
Key Responsibilities:
- Issue controlled manufacturing and testing documents to Manufacturing and Quality Control as per the production schedule
- Monitor the equipment program, including calibration and preventative maintenance timelines, and perform quality assurance sign-off for equipment work orders
- Manage the issuance and reconciliation of equipment and room logbooks
- Coordinate the release of raw materials after completion of review and approval of supporting documentation, including supplier and quality control testing records
- Reconcile, file, and archive all quality-controlled records, ensuring proper document storage and coordinating off-site document storage as necessary
- Provide pre-run line clearance to manufacturing and resolve discrepancies with document originators
- Develop and maintain controlled label stock, set inventory safety stocks, and manage printer supplies
- Support batch record review and revisions of SOPs (Standard Operating Procedures) to improve processes and maintain quality standards
- Actively participate in the development of the site's quality and safety culture
Qualifications:
- Education: BA/BS in Chemistry or a science-related field preferred, or equivalent from a two-year college or technical school
- Experience: A minimum of 2 years of experience in quality assurance, including familiarity with cGMP and ISO standards
- Technical Skills: Proficiency in MS Word, PowerPoint, Excel
- Other Skills:
- Strong understanding of Quality Assurance/Quality Control in a regulated environment
- Familiarity with lab equipment operation and setup
- Ability to read, analyze, and interpret technical procedures or regulations
- Excellent written and verbal communication skills
- Ability to work effectively across teams and interface with all levels of the organization
Preferred Skills:
- Experience in a biopharmaceutical or GMP-compliant environment
- Strong organizational and time-management skills
- Attention to detail and problem-solving capabilities
Compensation:
- Pay Rate: $23.00/hour (W2)
- Shift Differential: $2.75/hour
- Employment Type: Contract
- FLSA Status: Non-Exempt
- Work Environment: Onsite
Work Schedule:
- Night Shift: 12-hour shifts (3 on, 2 off, 2 on, 3 off)
This is a great opportunity for a Quality Assurance professional with document control experience to join a growing biopharmaceutical company. If you thrive in a regulated environment and enjoy working with a collaborative team, we encourage you to apply.
Salary : $3 - $23
