Contract Senior Specialist, Manufacturing Quality Records

Actalent • Louisville, CO • 5h ago

We are seeking a highly capable contractor to own and execute quality event investigations within a dynamic GMP manufacturing environment. The role involves investigating manufacturing-related quality events and delivering well-documented deviation investigation records on time. The contractor will also own change control records and manage continuous improvement initiatives to enhance GMP efficiency. This position requires the ability to independently track, manage, and close multiple quality events simultaneously, while working cross-functionally to foster a culture of quality, collaboration, transparency, and efficiency. This is a contract role based onsite at the GMP manufacturing facility in Louisville, CO.

Responsibilities

Own end-to-end deviation investigations and collaborate cross-functionally to ensure a thorough, risk-based investigation is conducted for each quality event commensurate with the event classification.

Ensure clarity, accuracy, and compliance of quality event documentation that meets procedural, regulatory, and phase-appropriate expectations.

Deliver high-quality deviation investigation reports that are complete, concise, clear, and submitted within defined timelines.

Own change control records and manage effective execution and closure by drafting organized, well-structured change action plans and driving implementation.

Manage continuous improvement initiatives from concept through execution by tracking progress with owners and stakeholders.

Communicate status of investigations, quality event records (Deviations, Change Controls, CAPAs) and Continuous Improvement projects at cross-functional and manufacturing-specific group meetings.

Essential Skills

Bachelors in Chemical/Biological Engineering, Biochemistry, Cell & Molecular Biology or related discipline with a minimum of 8 years of experience.

Experience with deviation investigation and complex root cause investigational tools (e.g., fishbone, 6M).

Demonstrated ability to use risk-based decision-making in support of deviation investigation and quality event reporting.

Excellent written and verbal communication skills, with the proven ability to deliver clear, concise reports in a GMP manufacturing environment.

Strong interpersonal skills and the ability to build open, collaborative working relationships.

Ability to work in a fast-paced environment, meet deadlines, and prioritize work across multiple investigations and projects.

Project management skills, including the ability to independently track, manage, and close multiple quality events simultaneously.

Familiarity with electronic quality systems and standard GMP quality processes.

Additional Skills & Qualifications

Previous experience supporting audits or inspections.

Experience in cell therapy, gene therapy, biologics, or other aseptic GMP manufacturing operations.

Experience with Lean, Six Sigma, or other structured problem-solving methodologies (e.g. SIPOC, DMAIC).

Work Environment

The position requires the ability to gown aseptically and work in a Clean Room environment. The candidate must be able to work while gowned for extended periods, including standing for long periods. Additionally, the role involves working in an office setting for extended periods. This is an onsite position requiring attendance 5 days per week

Job Type & Location

This is a Contract position based out of Louisville, CO.

Pay and Benefits

The pay range for this position is $52.72 - $65.12/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 Louisville,CO.

Application Deadline

This position is anticipated to close on Jan 12, 2026.

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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