HIRING NOW: Sr. Quality Control Specialist

INTERESTED IN THIS ROLE? Apply today and reach out directly to Grace Williams at grawilliams@actalentservices .com (grawilliams@actalentservices.com) with an updated resume!

Job Description

Sr. Quality Control Specialist for our new state-of-the-art facility in Indianapolis, dedicated to the commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability. The top priority for this position will be quality testing for same-day batch release.

Responsibilities

• Assist with the setup phase, including training on SOPs, safety, and on-the-job training for quality control methods.

• Assist with IQ/OQ/PQ of new equipment and instrument software.

• Draft and review documents such as SOPs, forms, FMECA, tech transfer protocol, and analytical method validation protocols.

• Implement, improve, and fully validate quality control methods.

• Perform quality testing for batch release within hours of production.

• Follow EHS regulations and guidelines including NRC (ALARA), OSHA, EPA, and chemical waste disposal.

• Adhere to SOPs, cGMP requirements, company policies, and regulatory requirements.

• Maintain constant readiness for regulatory inspection.

• Verify calibration and qualification status of instruments before testing.

• Gather raw materials and confirm they are not expired.

• Perform system suitability testing of instruments.

• Conduct chemistry and microbial testing on raw materials, APIs, in-process materials, and finished drug products.

• Complete and review documentation including test records, equipment logs, and other records.

• Monitor equipment for failures or concerning trends, report problems, and troubleshoot if possible.

• Assist with receiving deliveries, obtaining documentation for raw material acceptance, and coordinating third-party testing.

• Help maintain backup supplies including spare parts, consumables, and PPE.

• Dispose of waste and clean the laboratory.

• Train new employees.

• Promote a culture of quality and continuous improvement.

• Assist with quality events such as deviations, OOT/OOS, CAPAs, change controls, recalls, complaints, audits, inspections, and investigations.

• Assist with repeating equipment qualification and method validation as needed.

Essential Skills

• Bachelor's Degree in Life Science or related field.

• 3+ years of quality control experience within the pharmaceutical industry OR 5+ years of quality control experience within a regulated industry (food/beverage, cosmetic, etc.).

• Strong experience in method development and validation, particularly with HPLC.

Additional Skills & Qualifications

• Radiopharmaceutical experience.

• Experience in writing and revising SOPs.

• Familiarity with software such as eQMS, LIMS, and BMS.

• Experience with new facility systems, construction, and qualification.

• Gamma spectroscopy experience.

Work Environment

The facility environment includes working in a sterile manufacturing and clean room setting, using advanced equipment and technologies.

INTERESTED IN THIS ROLE? SEE BELOW TO APPLY NOW FOR IMMEDIATE CONSIDERTATION:

• We are actively hiring and interviewing for this position - Apply today to be in consideration. I will be conducting phone interviews as early as today. All candidates will be considered within 24 hours of reaching out directly to Grace Williams.

• Apply to Grace Williams at grawilliams@actalentservices. com or CALL (317-567 -6610) with your updated resume, brief intro about your interest, what method of communication works best for you (i.e., call, email, text)

Pay and Benefits

The pay range for this position is $33.65 - $38.46/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 Indianapolis,IN.

Application Deadline

This position is anticipated to close on Mar 17, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.