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HIRING NOW: Lead Sr. QC Specialist for a leading Biotech company in Indianapolis!

Interested in this role? Reach out directly to apply TODAY to Abby Vaughn at abvaughn@actalentservices .com (grawilliams@actalentservices.com)

Summary:

We are working with a fast-growing clinical stage biotech company focused on finding ways to impact and beat cancer! We are looking for a Lead Sr. QC Specialist to join their new state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. This position offers the opportunity to help establish standards and processes for the new facility and will set a strong example for other personnel in the lab.

This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability. This role should set a strong example for other personnel for determination to overcome obstacles, striving toward ambitious goals and timelines for this new facility, and a service-oriented focus on helping cancer patients. The top priority for this position will be QC testing for same-day batch release.

The Sr. Lead QC Specialist will focus on different area's throughout the progression:

1) Setup Phase

• Training: SOPs, safety (radiation, industrial), on-the-job training for QC methods

• Assist with validation of new equipment and instrument software; supervise/learn from field engineers when they are on-site.

• Draft/review of documents: SOPs, analytical method validation protocols, etc

• QC methods: tech transfer, implementation, improvements, full validation

2) Production Phase - Top Priority: QC testing for batch release within hours of production

• All tasks from the Setup Phase that continue into Production Phase.

• Safety and following all EHS regulations/guidelines, OSHA, EPA, chemical, waste disposal, etc.

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

• Regulatory compliance: maintain constant readiness for inspection

• Day-of-use setup before QC testing: calibration of instruments, raw material inspection, etc.

3) Testing: Chemistry QC (raw materials, in-process materials, finished drug products) and Microbial

• Carefully complete documentation: paper/electronic QC test records, equipment logs, other records, perform technical review of completed documents

• Materials: Help receive deliveries; obtain documentation for raw material acceptance; perform in-house testing; coordinate 3rd party testing

• Help maintain backup supplies for QC: spare parts, consumables, PPE, other supplies

• Waste disposal and cleaning of QC lab

4) Continuous Improvement

• Embody and promote a culture of quality and continuous improvement

• Strive toward ambitious goals/timelines

• Draft/review SOPs and other documents

• Assist with Quality Events (deviations, OOT/OOS, CAPAs, change controls, recalls, complaints, FMEAs, audits, inspections, investigations)

• Assist with repeating equipment qualification and/or method validation as needed

Skills:

GMP, Laboratory, Quality Control, Chemistry, Six sigma, Process improvement, Batch Record, cGMP, Cyclotron, Particle Accelerator, Sample Prep, Clean Room, radiopharmaceutical, nuclear medicine, isolator, sterile environment, sterile manufacturing, vendor qualification, method development, Method Validation, Aseptic, Pharmaceutical, HPLC, Radiation Safety, Gamma Spectroscopy

Qualifications:

1) Bachelor Degree in Life Science or related field

2) 3+ years of QC experience within pharma industry OR 5+ years of QC experience within regulated industry (food/bev, cosmetic, etc.)

3) Strong experience performing method development/validation (HPLC would be most helpful instrument)

4) Experience with Radiopharmaceutical, SOP writing/revision, QMS/LIMS software, new facility set up, or Gamma spectroscopy would be preferred

Environment:

Consultant will start off working 1st shift (7am-4pm) Monday-Friday with some flexibility. Once production phase is reached, which is likely Q2 next year, the individual will need to be flexible with working on a 2nd shift.

INTERESTED IN THIS ROLE? Apply TODAY

• We are actively hiring and interviewing for this position and I will be conducting phone interviews as early as today. All candidates will be considered within 24 hours of reaching out directly to Abby Vaughn.

• Apply with your updated resume, brief intro about your interest, what method of communication works best for you (i.e., call, email, text) to abvaughn@actalentservices. com or call (317-567 -6605)

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.