GMP Manufacturing Associate II (Weekend Overnights)

Job Summary: 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.

Schedule

• Thursday through Sunday
• 10-hour shifts: 6:30 PM – 4:00 AM
• Highly flexible schedule that may change based on vacation coverage needs
• Frequent changes in assigned areas and job responsibilities

Key Accountabilities

• 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

Responsibilities

Safety

• Adhere to PPE and machine operation safety procedures
• Report hazards, malfunctions, and incidents promptly

Quality

• 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

Manufacturing & Delivery

• 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

Continuous Improvement & Training

• Actively contribute 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

Company Values

• 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

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

Physical Requirements

• Stand for extended periods; perform repetitive tasks
• Lift/move up to 25 lbs as needed
• Wear cleanroom attire (gown, mask, gloves) for prolonged periods

Pay

The pay range for this role is: $19.90-$30.80/Hourly. The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles.

Benefits

• 401(k) with up to a 6% employer match and no vesting period
• Employee stock purchase plan
• “Flexible time off” for salaried employees
• For hourly employees: accrual of three to five weeks’ vacation annually (based on tenure)
• Accrual of 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
• Incentives may also be provided as part of employee compensation
• For sales roles: sales incentive (i.e., commission) under the applicable plan terms
• For non-sales roles: discretionary annual bonus, the target amount of which varies based on the applicable role
• Eligibility to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role