Senior Quality Specialist – Bloomington, IN

Title:  Senior Quality Specialist

Location: Bloomington, IN

Schedule:  Mon-Fri; 1st Shift

Type: Direct Hire

Start date:  ASAP

Looking to hire experienced Senior Quality Specialists to join one of our Global Pharmaceutical clients ASAP!!

Responsibilities:
Support the effective and compliant execution of tech transfer activities and development of necessary quality systems at the EM sites and associated off-site storage locations.

Support site qualification activities and development of quality agreements in accordance with Company standards.

Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure Company products/processes comply with cGMP requirements.

Support regulatory submission activities, and lead inspection readiness activities in partnership to support global health authority approvals.

Following successful tech transfer, support quality oversight for day-to-day production activities, including deviation and CPA management, escalation of critical issues, and change control.

Monitor quality performance and proactively identify risks and mitigation plans through benchmarking and knowledge sharing.

Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence.

Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc) to meet patient supply requirements Apply cGMP regulations and other FDA and international requirements to all aspects of the position.

Requirements:
Bachelor’s Degree with a concentration in engineering, science, or an equivalent technical discipline Minimum of 8 years working in an FDA regulated environment Experience in pharmaceutical aseptic manufacturing operations and Quality Assurance Detailed knowledge of cGMPs related to pharmaceutical production Ability to quickly process complex information and make critical decisions with limited information required Experience in Vaccine Production/ QA Proficient in applying process excellence tools and methodologies Experience working with External Manufacturers or Labs Previous experience with a CMO

Joule, a System One division is a leader in specialized workforce solutions and integrated services.

With more than 6,000 employees and roughly 50 offices throughout the U.S.

we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.  For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.