Quality Assurance Specialist

Actively Hiring: QA Specialist

(Location: Indianapolis, IN)

Description:

This company is the world’s largest nuclear medicine company with more than a century of industry experience. They develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. This company delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. Currently they are looking to expand the Indianapolis operation by adding a Sr QC Technician to their team.

Summary of Position:

The Quality Assurance Specialist position reports directly to the Manager Quality Assurance. The Quality Assurance Specialist is responsible for implementing and supporting the Quality Management System (QMS) in accordance with Company policies and procedures.

Essential Functions:

• Write, revise, review, and approve site procedures and policies.

• Review and approve investigations and associated CAPAs.

• Participates in regulatory agency (i.e. FDA, etc.) inspections.

• Investigate or serve as GMP QA approver for customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented.

• Assemble, analyze and report QA data (metrics) to ensure regulatory compliance, identify trends and to identify areas of improvement.

• Review Batch Records and provide final product disposition.

• Conducts internal audits of GMP Quality Systems and sub systems.

• Aide in assessing risk during Vendor Qualifications or Material Assessments.

• Conducts incoming material disposition.

• Document Control, Training, Quality Systems back-up and key trainer.

• Reviews and assesses in-house solution preparation and external material testing.

• Conducts Vendor Qualification and reviews.

• Review and compile the Annual Product Quality Review.

• Ability to adapt quickly in a fast-paced dynamic environment.

• Ability to communicate with and positively influence broad and diverse populations within and outside the organization.

Skills:

Quality assurance, GMP, Batch Record Review, cGMP, Laboratory, Aseptic, CAPA, Vendor Qualification, QMS, Quality Management System, Quality System, Document Control, Audit, Quality Assurance Testing, Deviation, Material Assessment, Write SOP, Review SOP, Method Development, Method Validation

Top Skills Details:

Quality assurance,GMP,Batch Record Review

Additional Skills & Qualifications:

Must Haves:

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

2) 3+ years of relevant GMP QA experience (Most must be from pharma)

3) Strong experience with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.

Plus:

1) Method development/validation experience

2) Working knowledge of cGMP regulations and guidelines and their application in a controlled aseptic environment is strongly preferred

3) Any radiopharma experience is highly valued

Experience Level:

Intermediate Level

Interviewing ASAP

• Reach out directly and apply to Jack McCue to be immediately in consideration for our current opportunities with your updated resume, a brief intro about you and your skills, and what method of communication works best for you (i.e., call, email, text)

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

Actalent is an equal opportunity employer.

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.