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Hiring Now: QC Instrumentation Manager

INTERESTED IN THIS ROLE? Apply and reach out TODAY directly to Grace Williams for immediate consideration with an updated resume grawilliams@actalentservices .com

Overview:

Supporting one of the world’s largest nuclear medicine company that manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Currently they are looking to expand the Indianapolis operation by adding a QC Instrumentation Manager to their team.

Description:

The Quality Control Instrumentation Manager is responsible for leading the implementation, and optimization of analytical instrumentation within the Quality Control department. This role involves hands-on project management through to operational readiness. The ideal candidate will possess a deep technical understanding of analytical techniques, project management skills, and the ability to work collaboratively with cross-functional teams to enhance our testing capabilities and ensure regulatory compliance. The Quality Control Instrumentation Manager provides technical counsel concerning the scientific content of methods, analytical testing, instrumentation, evaluation, and interpretation of laboratory data, assisting in OOS investigations, and other QC related issues as required.

Essential Functions:

• Lead cross-functional projects for the installation and qualification of new analytical instrumentation, ensuring projects are completed on time, within budget, and in compliance with regulatory standards.

• Perform Preventative Maintenance and Demand Maintenance on QC instruments and equipment Author and execute analytical method, and equipment/instrument IQ/OQ/PQ protocols.

• Collaborate with equipment vendors and service providers for procurement, installation, and troubleshooting of analytical instruments.

• Negotiate contracts and manage vendor relationships to support project goals.

• Author Standard Operating Procedures for new instruments/software

• Perform routine testing to support the release of finished product, raw materials, API

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)

• Author Change Controls, Protocols, Corrective and Preventive Action items and Periodic Reviews.

• Assure compliance with department training and qualification.

• Work safely with radioactivity and ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.

• Provides technical counsel concerning the scientific content of methods, analytical testing of samples, evaluation and interpretation of laboratory results, and other QC related issues as required.

• Assists laboratory personnel with the process of instrument repair and troubleshooting, qualification and validation, and training.

• Work closely with the quality control team, research and development, manufacturing, and external partners to ensure seamless integration of new instrumentation into existing processes.

• Provide training and support to staff on new equipment and methodologies.

• Ensure all analytical instrumentation and associated processes comply with regulatory requirements and industry best practices.

• Maintain accurate documentation and records for equipment validation, calibration, and maintenance.

• Develop and optimize analytical methods and testing processes for new equipment. Ensure robust, accurate, and efficient testing capabilities are established and maintained.

Qualifications:

1) Bachelor's or Master's Degree in Life Science

2) 3-5+ years of analytical chemistry experience (HPLC, GC, ICP, FTIR, UV, TLC, and Mass Spec most relevant)

3) 3+ year in a leadership role managing analytical instrumentation projects

Miscellaneous:

• Company is continuously growing with a national footprint.

• Candidates will have the chance to learn Leadership responsibilities and be looked at as a true leader.

• This team is very Employee-Focused with Competitive Incentives and career pathways.

• Benefits: National Paid Holidays, Dental, Vision, Health, 401k Savings, Employee Assistance and Abenity program, PTO

INTERESTED IN THIS ROLE? Apply directly today:

• I am actively hiring for this position and conducting phone interviews as early as today. All candidates will be considered immediately within 24 hours of applying directly to Grace Williams.

• HOW TO APPLY: Email your updated resume, brief intro about your interest, preferred method of communication for you (i.e., call, email, text) to grawilliams@actalentservices. com or call (317-567 -6610)

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.