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18 days old

Senior Quality Specialist (PIP) - Bloomington IN

Kelly Services
Bloomington, IN 47407
**Senior Quality Specialist (Person In Plant)**


Bloomington IN


Kelly Science and Clinical is hiring a **Senior Quality Specialist** to work directly with one of our major pharmaceutical clients. This role is a full-time, salaried opportunity offering our enhanced benefit package. As a Kelly employee within this group, you will be eligible for our benefit options including Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. All Kelly FSP employees receive annual performance reviews.


Must be local to: Bloomington, IN


**Key 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 standards.

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

+ Support regulatory submission activities, and lead inspection readiness activities in partnership with EM site 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 EM 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.


**Experience / Knowledge** **_Required_** **:**


+ Bachelors 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

+ Strong interpersonal and written/oral communication skills

+ Ability to quickly process complex information and make critical decisions with limited information required

+ Advanced degrees are a plus and may reduce the experience required


**Experience / Knowledge** **_Preferred_** **:**


+ Experience in **Vaccine** Production/ QA

+ Proficient in applying process excellence tools and methodologies

+ Experience working with External Manufacturers or Labs


UP TO 80% time to be on site at External Manufacturer possible.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-08 Expires: 2021-11-08

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Senior Quality Specialist (PIP) - Bloomington IN

Kelly Services
Bloomington, IN 47407

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