Senior Analyst, QC Analytical

Job Description

Job Description

Senior Analyst, Quality Control

Job Description

The Senior Analyst, Quality Control plays a key role in a high-performing, people-focused, and inclusive quality organization by performing and reviewing QC analytical testing to support product release, stability, and in-process control for advanced immunotherapy products. This role combines hands-on bench work, sample management, and method support with active participation in continuous improvement initiatives in a cGMP-regulated laboratory environment. The position is ideal for an experienced QC professional with a molecular biology background who enjoys collaborative problem-solving, operational excellence, and contributing to a mission-driven culture focused on improving outcomes for patients and their families.

Responsibilities

• Demonstrate and model core organizational values as part of a high-performing, people-focused, inclusive, and collaborative quality team.
• Perform QC analytical laboratory testing under cGMP, with management supervision, in support of product release, stability studies, and in-process testing.
• Conduct bioanalytical testing using methods such as ELISA, digital droplet PCR (ddPCR), flow-based assays, flow cytometry, and cell-based assays, ensuring accuracy, precision, and compliance with approved methods.
• Review QC data and documentation for completeness, accuracy, and adherence to SOPs, methods, and regulatory expectations.
• Execute sample management activities including sample receipt, verification, aliquoting, labeling, storage, and maintaining sample chain of custody for manufacturing and QC testing.
• Support stability programs by coordinating and performing stability timepoint pulls and associated testing according to established protocols.
• Collaborate closely with the Analytical Development team to perform testing in support of method qualification and transfer activities.
• Provide QC input and perspective during method troubleshooting and optimization, partnering with cross-functional teams to resolve technical issues.
• Participate in Operational Excellence and Continuous Improvement initiatives, applying OE/CI philosophies and tools in a regulated laboratory environment to enhance efficiency and quality.
• Independently own and complete daily laboratory tasks such as inventory management, critical reagent qualification, cell passaging, and general bench work.
• Support QC microbiology activities as needed, including execution of microbiology assays and compendial methods, and application of aseptic techniques.
• Ensure all work follows approved documents, including SOPs, test methods, protocols, and relevant regulatory guidance, and promptly escalate deviations or issues.
• Maintain laboratory readiness by supporting equipment use, basic maintenance, and documentation in shared lab spaces.
• Contribute to the development and maintenance of quality systems and laboratory startup activities as applicable.
• Work effectively within a shared resource “One QC” model, supporting both QC analytical and microbiology functions based on operational needs.
• Communicate clearly with team members, raise questions during training, and proactively seek clarification to ensure full understanding of procedures.
• Identify opportunities for process improvements, suggest enhancements to workflows and assays, and actively participate in implementing better ways of working.
• Balance independent work with collaborative scheduling in a pull-based system, self-scheduling tasks to meet team and project priorities.
• Uphold a strong culture of safety by correctly using personal protective equipment, following cleanroom and laboratory procedures, and maintaining a safe work environment.

Essential Skills

• Bachelor's degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or another life science discipline, or an equivalent combination of advanced education and experience.
• 3–5 years of experience in a cGMP-regulated QC environment at a Senior analyst level.
• Demonstrated quality control experience in a cGMP laboratory setting.
• Molecular biology background with hands-on experience in digital PCR (including ddPCR), ELISA, flow cytometry, and cell-based assays.
• Proficiency in executing laboratory work according to approved SOPs, test methods, protocols, and related documentation.
• Basic knowledge of relevant pharmaceutical regulations and regulatory guidance applicable to QC laboratories.
• Experience performing bioanalytical testing such as ELISA, flow-based assays, and ddPCR in a regulated environment.
• Ability to manage sample handling workflows including sample receipt, aliquoting, storage, and chain-of-custody documentation.
• Strong bench skills in a QC laboratory, including familiarity with compendial assays and general analytical techniques.
• Ability to gown aseptically and work in a cleanroom environment in compliance with aseptic practices.
• Ability to wear personal protective equipment, including gloves, protective clothing, and eye protection, for extended periods.
• Physical ability to work around laboratories and manufacturing areas and regularly lift up to 20 pounds.
• Capability to work independently while contributing effectively as part of a team in a shared resource model.
• Strong communication skills with the confidence to ask questions, speak up when something is unclear, and actively participate in training.
• Demonstrated passion for teamwork, commitment to shared purpose, and support for a positive, inclusive workplace culture.

Additional Skills & Qualifications

• Experience with laboratory startup activities, including implementation or support of quality systems and analytical methods.
• Laboratory experience with molecular assays such as digital PCR, flow cytometry, ELISA, and cell-based test methods beyond minimum requirements.
• Experience working in a cGMP cell and gene therapy manufacturing and/or testing facility.
• QC microbiology experience and proficiency with aseptic technique.
• Familiarity with compendial microbiology assays and related QC testing.
• Experience supporting or participating in Operational Excellence or Continuous Improvement programs in a regulated environment.
• Ability to excel in a collaborative environment through effective knowledge sharing and cross-functional teamwork.
• Comfort working in a shared laboratory space with a “One QC” model that integrates analytical and microbiology responsibilities.
• Willingness to go beyond routine execution by suggesting improvements to assays, workflows, and processes.
• Proactive mindset with the ability to self-schedule work within a pull-based scheduling system and adapt to changing priorities.
• Commitment to diversity, equity, and inclusion, and enthusiasm for contributing to a mission-driven organization focused on transformative cancer therapies.

Job Type & Location

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

The pay range for this position is $34.16 - $42.20/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)

This is a fully onsite position in Louisville,CO.

This position is anticipated to close on Aug 10, 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 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 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 process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.