Pharmaceutical Regulated - Quality Operations Lead

ACTalent; Minnetonka (MN); On-site; USD 37,000 - 44,000; Full time

Job summary

Actalent is seeking a Quality Operations Lead to serve as the quality representative in a regulated manufacturing environment. You will work closely with production teams to monitor compliance, investigate quality concerns, and drive continuous process improvements to uphold product excellence and regulatory standards.

Key duties include performing inspections, maintaining quality documentation, and supporting lean initiatives on the manufacturing floor.

Qualifications

• Two+ years in a regulated manufacturing environment preferred.
• Experience supporting QA activities within production or packaging.
• Familiarity with GMP or similar regulated quality standards.
• Experience reviewing production documentation and quality records.
• Familiarity with in-process inspections, production audits, and quality verification.

Responsibilities

• Monitor manufacturing and packaging activities to ensure quality specifications and regulatory expectations are met.
• Maintain and enhance quality management systems and compliance programs.
• Conduct routine quality inspections and process audits during production.
• Verify adherence to procedures, specifications, and manufacturing practices.
• Review production records and quality documents for accuracy and completeness.
• Ensure quality documentation is completed and maintained per procedures.
• Promote quality awareness and best practices among operations personnel.
• Collaborate with cross-functional teams to address quality concerns and ensure product acceptance criteria.
• Support internal audits, inspections, and compliance activities as needed.
• Lead root cause analysis and corrective actions for quality issues.

Skills

GMP knowledge

Quality assurance

Root cause analysis

Documentation & record-keeping

Quality inspections

Cross-functional collaboration

Attention to detail

On-floor manufacturing support

Education

Bachelor's or Associate degree in science/engineering

Tools

Microsoft Office

Job description

Quality Operations Lead

Position Summary

The Quality Operations Lead serves as a key quality representative within a regulated manufacturing environment, ensuring products are produced, packaged, and documented in accordance with established quality standards and industry regulations. This role partners closely with manufacturing teams to support day-to-day operations, monitor compliance, investigate quality concerns, and drive continuous process improvements. The successful candidate will help maintain effective quality systems while fostering a culture focused on product excellence, operational efficiency, and regulatory compliance.

Key Responsibilities

• Monitor manufacturing and packaging activities to ensure products consistently meet quality specifications and regulatory expectations.
• Support the ongoing maintenance and enhancement of quality management systems and compliance programs.
• Conduct routine quality inspections and process audits throughout production operations.
• Verify adherence to established procedures, specifications, and documented manufacturing practices.
• Review production records, manufacturing documentation, and quality records for accuracy and completion.
• Ensure required quality documentation is completed accurately and maintained according to established procedures.
• Evaluate compliance with standard operating procedures, work instructions, and quality guidelines across assigned areas.
• Promote quality awareness and reinforce best practices among operations personnel.
• Document, investigate, and assist in resolving quality events, deviations, nonconformances, and product concerns.
• Participate in root cause analysis and corrective action activities related to quality issues.
• Confirm cleaning, sanitation, and line clearance activities are properly completed and documented.
• Perform visual inspections of products, materials, and packaging components.
• Support lean manufacturing and continuous improvement initiatives aimed at improving efficiency and reducing waste.
• Utilize quality tools and performance metrics to identify opportunities for process improvement.
• Assist in maintaining workplace organization and operational excellence initiatives.
• Provide guidance and training to production teams regarding quality expectations and compliance requirements.
• Collaborate with cross-functional teams to address quality concerns and ensure product acceptance criteria are achieved.
• Support internal audits, inspections, and compliance activities as needed.
• Effectively manage priorities in a dynamic manufacturing environment with changing production demands.
• Perform additional quality-related duties and projects as assigned.

Required Qualifications

• Minimum of two years of experience in a regulated manufacturing environment preferred.
• Experience supporting quality assurance activities within production or packaging operations.
• Working knowledge of Good Manufacturing Practices (GMP) or similar regulated quality standards.
• Experience reviewing production documentation and quality records.
• Familiarity with in-process inspections, production audits, and quality verification activities.
• Understanding of quality systems, SOPs, and controlled documentation practices.
• Experience investigating quality incidents, deviations, or nonconforming materials.
• Strong attention to detail with the ability to maintain accurate records and documentation.
• Strong organizational and multitasking capabilities in a fast-paced environment.
• Effective verbal and written communication skills with the ability to influence and collaborate across departments.
• Ability to understand and follow detailed procedures and technical documentation.
• Proficiency with Microsoft Office applications and basic data entry systems.
• Ability to work on the manufacturing floor for extended periods, including standing, walking, and conducting inspections.
• Flexibility to adapt to changing schedules, priorities, and business needs.

Preferred Qualifications

• Associate's or Bachelor's degree in a scientific, technical, or related discipline, or equivalent industry experience.
• Experience within consumer products, healthcare products, personal care, food, beverage, biotechnology, pharmaceutical, or medical device manufacturing.
• Knowledge of visual inspection techniques and quality control methodologies.
• Familiarity with continuous improvement programs, lean manufacturing principles, or workplace organization initiatives.
• Demonstrated ability to promote quality-focused behaviors and support compliance objectives.
• Strong problem-solving skills with experience identifying and implementing process improvements.
• Interest in long-term career advancement within quality, compliance, or operations leadership.

Work Environment

This position is primarily based within a manufacturing facility and requires a significant presence on the production floor. The work environment is fast-paced and deadline-driven, requiring frequent interaction with production, maintenance, and quality personnel. Employees should be comfortable working in a regulated setting with varying production schedules, changing priorities, and occasional overtime requirements.

The role involves prolonged standing, walking, routine inspections, and active engagement with manufacturing operations throughout the shift. Candidates should be comfortable working around production equipment, following established safety procedures, and adapting to evolving operational needs. Opportunities for professional growth and advancement are available for individuals who demonstrate strong performance and leadership potential.

Job Type & Location

This is a Contract to Hire position based out of Minnetonka, MN.

Pay and Benefits

The pay range for this position is $26.50 - $32.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract to Hire position based out of Minnetonka, MN.

Application Deadline

This position is anticipated to close on Nov 24, 2026.

Workplace Type

This is a fully onsite position in Minnetonka,MN.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.