GMP Quality Auditor & Process Coach

Actalent; Chaska (MN); On-site; USD 36,000 - 41,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision insurance

401(k) retirement plan

Job summary

Actalent is seeking a Quality Operations Technician to ensure product quality by auditing the facility and production lines, evaluating materials, and driving continuous improvement. You will document deviations, train staff, and maintain GMP documentation in a fast-paced manufacturing setting.

The role emphasizes lean practices, 5S, and adherence to regulatory requirements, with a first-shift schedule in Chaska, MN on a contract-to-hire basis.

Qualifications

• Quality assurance experience in a GMP manufacturing environment.
• Working knowledge of cGMP and 21CFR drug manufacturing regulations.
• Detailed understanding of quality work instructions and related SOPs.
• Ability to multitask, demonstrate a sense of urgency, and organize effectively.
• Strong interpersonal and coaching skills.

Responsibilities

• Complete packaging batch record paperwork and audit manufacturing lines to maintain a world-class control program.
• Document and escalate quality events (deviations, non-conformances, potential issues) for effective decision-making.
• Ensure compliance with SOPs, work instructions, and test procedures; proactively update them for improvements.
• Maintain GMP-compliant documentation records.
• Provide technical direction and training to manufacturing personnel; foster a culture of quality.

Skills

Quality assurance

GMP knowledge

21 CFR knowledge

SOPs familiarity

Interpersonal coaching

Multitasking

Education

Bachelor’s degree in Chemistry or Biology

Job description

Actalent is seeking a Quality Operations Technician to ensure product quality by auditing the facility and production lines, evaluating materials, and driving continuous improvement. You will document deviations, train staff, and maintain GMP documentation in a fast-paced manufacturing setting.

The role emphasizes lean practices, 5S, and adherence to regulatory requirements, with a first-shift schedule in Chaska, MN on a contract-to-hire basis.