GMP Manufacturing Associate II (Weekend Overnights)
About The Position
The cGMP II is a skilled operator position on the weekend floater vacation relief team within Plasma manufacturing operations. Building on the foundation of the cGMP I role, this position performs production tasks while providing support and assistance to the Area Leader to help ensure the team meets production, quality, and safety goals. This role is ideal for reliable, experienced operators who can work independently, support leadership, and contribute to the overall success of the weekend team. The GMP Associate II builds on the skills of Associate I by independently operating and troubleshooting manufacturing equipment, maintaining production flow, and ensuring compliance with GMP, GDP, and safety standards. This role also assists with training new associates, supports continuous improvement projects, and contributes to the consistent delivery of safe, effective medical devices.
Requirements
- High school diploma or equivalent.
- 1–2 years of experience in a GMP-regulated manufacturing environment (medical device, pharma, or biotech preferred).
- Strong understanding of GMP/GDP principles.
- Experience with equipment operation and troubleshooting.
- Cleanroom experience preferred.
- Strong teamwork, communication, and attention to detail.
- Basic computer and manufacturing system skills.
Nice To Haves
- Cleanroom experience
Responsibilities
- Demonstrate proficiency on all machinery and processes across Plasma departments
- Perform production tasks accurately, efficiently, and in full compliance with cGMP standards
- Assist the Area Leader with daily coordination, task prioritization, and team support
- Help train and coach cGMP I team members as needed
- Identify and communicate issues, deviations, or opportunities for improvement
- Support a culture of accountability, safety, and continuous improvement
- Remain flexible and adaptable to changing priorities, areas, and work assignments
- Adhere to PPE and machine operation safety procedures.
- Report hazards, malfunctions, and incidents promptly.
- Maintain cleanroom standards and enforce gowning compliance.
- Complete and review production records, logs, and maintenance documentation.
- Perform in-process inspections and ensure products meet specifications.
- Load/replenish materials and ensure continuous production flow.
- Assemble components/subassemblies per GMP and work instructions.
- Operate equipment, diagnose and resolve HMI/automation faults, and perform equipment adjustments or troubleshooting.
- Escalate complex technical issues to maintenance/engineering.
- Perform cleaning, sanitization, and equipment care per SOPs.
- Take ownership of Total Preventive Maintenance (TPM) activities to ensure equipment reliability and readiness.
- Actively contributes to process improvements and waste reduction initiatives.
- Support lean practices and problem-solving activities.
- Assist with onboarding and training new associates in GMP practices and equipment operation.
- Work cross-functionally with Quality and Engineering to meet/exceed production targets.
- Act as a role model for professionalism and compliance.
- Uphold company policies and procedures, performing additional duties as needed to support production.
- Communicate effectively with supervisors and team members to resolve issues and ensure smooth production flow.
Benefits
- 401(k) with up to a 6% employer match and no vesting period
- employee stock purchase plan
- flexible time off for salaried employees
- three to five weeks’ vacation annually (based on tenure) for hourly employees
- up to 64 hours (annually) of paid sick time
- paid and/or floating holidays
- parental leave
- short- and long-term disability insurance
- tuition reimbursement
- health and welfare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
