GMP Quality & Manufacturing Lead

ACTalent; Chaska (MN); Presencial; USD 36.000 - 41.000; Jornada completa

Descripción de la vacante

Actalent is seeking a Quality Operations Lead for its Chaska, MN location. This contract-to-hire role runs Monday–Friday, 6 AM to 2 PM, onsite, focusing on maintaining GMP-compliant quality throughout filling and cartoning lines.

Responsibilities include audits, paperwork accuracy, deviation handling, and coaching line personnel on regulatory requirements to ensure customer standards are met. Benefits and eligibility may apply.

Formación

• Quality assurance experience in GMP manufacturing environment.
• Experience in batch record review and floor-based QA supporting manufacturing.
• Knowledge of quality procedures, SOPs, and work instructions.
• Strong attention to detail and ability to multitask in a fast-paced environment.
• Strong communication and interpersonal skills.
• Proficient with Microsoft Office and basic math.
• Ability to read and follow written procedures and specifications in English.

Responsabilidades

• Oversee production lines during filling and cartoning operations to ensure quality products are produced and all quality, customer, and regulatory requirements are met.
• Maintain and improve quality systems to support efficient, high-quality manufacturing.
• Perform in-process audits of manufacturing lines and ensure quality throughout the filling process.
• Complete all line paperwork accurately and in compliance with company and regulatory standards.
• Ensure compliance with current SOPs, work instructions, and test procedures.
• Promote a culture of quality and increase quality awareness across production.
• Document and investigate deviations and out-of-specification situations.
• Coach production personnel on quality and regulatory requirements.
• Ensure product quality specifications and customer standards are consistently met.
• Document and elevate quality events, including deviations and non-conformances.
• Verify that cleaning and sanitization procedures are completed correctly.
• Support practices and processes that eliminate waste throughout the department.
• Utilize tools to implement and maintain process improvements.
• Support 5S principles: Sort, Straighten, Shine, Standardize, and Sustain.
• Perform other duties as assigned.

Conocimientos

Quality assurance

Batch record review

Quality procedures

Attention to detail

Communication skills

Microsoft Office

Reading procedures in English

Educación

Bachelor's degree in Chemistry, Biology, or related science

2+ years GMP manufacturing experience

Descripción del empleo

Actalent is seeking a Quality Operations Lead for its Chaska, MN location. This contract-to-hire role runs Monday–Friday, 6 AM to 2 PM, onsite, focusing on maintaining GMP-compliant quality throughout filling and cartoning lines.

Responsibilities include audits, paperwork accuracy, deviation handling, and coaching line personnel on regulatory requirements to ensure customer standards are met. Benefits and eligibility may apply.