QC Bioassay Supervisor

Actalent • Berkeley, MO • 1d ago

QC Analytical Supervisor

Job Description

The QC Analytical Supervisor is responsible for supervising and developing staff to ensure routine activities comply with cGMP regulations and company standards, achieving both departmental and organizational goals. The role involves managing a team to support qualification assays, perform transfer and validation assays, oversee batch release, and conduct process and facility support testing. The supervisor will represent the department during regulatory agency and partner audits, provide technical expertise to resolve complex QC issues, and conduct training for QC analytical personnel. Additionally, the role supports establishing robust work processes and identifying continuous improvement opportunities.

Responsibilities

Provide leadership to staff by leading organizational change, developing and empowering team members, and fostering a climate that encourages motivation and engagement.

Create and coordinate work schedules for the team.

Offer technical and compliance guidance on test methods, qualification, validation, and transfer protocols. Revise/review specifications, SOPs, and other QC-Analytical documents.

Train new hires on department processes, procedures, and tools.

Interact with auditors and clients during visits and tours.

Oversee daily activities to ensure quality output and maintenance of schedules.

Support validation, qualification studies, or routine testing through in-lab assay execution.

Set objectives for staff and regularly review their progress.

Review and approve documentation generated by the team.

Lead investigations for deviations and assist in resolving OOS, complaints, discrepancies, and CAPA.

Notify Senior Management of potential quality or regulatory issues.

Communicate effectively with peers and staff to resolve technical issues and direct activities.

Support site safety initiatives.

Review FTE assessments to determine project requirements and resource allotment.

Perform other tasks as requested by Senior Management to support quality oversight.

Establish work plans and staffing for project phases and manage project personnel assignments.

Essential Skills

1+ year of experience managing processes or people.

5 years of experience working in a controlled environment (GLP or GMP regulated), with at least 1 year in the pharmaceutical industry.

Proficiency in cell and plate-based assays, including ELISA, cell maintenance, enzyme assays, protein binding, and potency assays.

Bachelor's Degree in a Biological Science-related field.

Extensive knowledge of GMP regulations and cGMP manufacturing environments.

Routine use of MS Excel, MS PowerPoint, and MS Word.

Additional Skills & Qualifications

Experience with plate assays and large molecules.

Outstanding technical writing skills.

Strong interpersonal skills, including active listening and conflict resolution.

Familiarity with project management concepts and tools.

Ability to interpret and implement Quality Standards.

Flexibility in problem-solving and work hours.

Ability to inspire innovation, collaboration, and team effectiveness.

Work Environment

This role is part of a QC Analytical team consisting of over 80 members, managing a team of 5-6 individuals with potential for growth. The position involves several months of training and learning processes in a dynamic and supportive environment that encourages professional development and growth.

Job Type & Location

This is a Contract to Hire position based out of Berkeley, Missouri.

Job Type & Location

This is a Contract to Hire position based out of Berkeley, MO.

Pay and Benefits

The pay range for this position is $40.00 - $48.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Berkeley,MO.

Application Deadline

This position is anticipated to close on Nov 6, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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