Join a high-impact manufacturing team dedicated to producing antibody products for life-saving in vitro diagnostic (IVD) use. This role is ideal for a detail-oriented professional looking to advance their technical career in a regulated cGMP environment. You will play a dual role: executing precise laboratory operations-including aseptic filling and complex packaging-while also utilizing advanced SAP and Excel skills to manage production planning and quality documentation.
location: Saint Louis, Missouri
job type: Contract
salary: $18 - 23 per hour
work hours: 9 to 5
education: High School
responsibilities:
Advanced Manufacturing & Filling: Execute aseptic techniques to fill, cap, and dispense antibody products using automated pumps, repeater pipettes, and laminar flow workstations.
Systems, Planning & SAP: Independently manage daily production goals using SAP and advanced Excel formulas; troubleshoot complex ERP issues (CORS, COR6N) and verify Bills of Materials (BOM).
Quality & Compliance: Maintain strict adherence to cGMP, FDA, and ISO 13485 regulations; lead area clearances, perform data verification, and participate in CAPA or production failure investigations.
Packaging & Assembly: Operate automated labeling equipment and manage kit assembly, ensuring 100% accuracy in final product quality and documentation.
Logistics & Completions: Conduct accurate ERP transactions, review paperwork for inconsistencies, and ensure finished goods are returned to appropriate temperature-controlled storage.
Leadership & Collaboration: Actively lead DMS Board meetings, author professional technical emails, and train fellow associates on production lines.
Continuous Improvement: Maintain a "6S" lean work environment and regularly submit Suggestions for Improvement (SFIs) to optimize laboratory safety and productivity.
qualifications:
Required:
- Bachelors degree with no experience OR High school diploma or GED required with a minimum of 1 year of Production or Manufacturing experience.
- Experience with SAP, SAP NEXT, or other ERP systems.
- A minimum of 1 year of experience with general laboratory equipment.
- Knowledge of and experience in a GMP facility, FDA QSRs, ISO 13485, or other related industry standards.
- Previous experience in FDA regulated biotechnology or pharmaceutical environment.
- Demonstrated knowledge and proficiency with Microsoft 365 products.
skills: ERP System, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Food and Drug Administration (FDA)
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.
