29 days old

Validations Specialist 3- Manufacturing, vaccines, quality experience a must

Kelly Services
Baltimore, MD 21217
**Kelly Services** is currently seeking a **mostly REMOTE Validation Specialist 3** near **Baltimore, MD** to work a contract assignment 12 **month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities includes:**

With Quality oversight, support the review and approval of equipment and process qualification/validation protocols and reports

With Quality oversight, support the review and approval of process flow diagrams/product descriptions and subsequent master batch records - focus on large molecule cell expansion/bioreactor/purification manufacturing

With quality oversight, support the investigation related to manufacturing deviations

Review batch documentation provided by contract manufacturers (CMO) and responsible for product release in accordance to Company Supply Chain (JSC) procedures

Ensure all required testing and documentation are provided and met release requirements. Including but not limited to:

Review CMO Certificates of Conformance for batch release. Verify CMO certificates contain required information to confirm compliance of product to GMP, Company Specification and Quality Agreement requirements. Ensure all documents are in compliance with good documentation practice, data integrity, and accuracy of batch information, including but not limited to lot number, expiry date, within target ranges, etc..

Ensure required Certificate of Analysis and Certificate of Conformance from bulk manufacturers and external laboratories are included and met specification.

Ensure documentation review meets the requirements as specified for each product

Generate Company certificate of release

Maintain high level oversight of individual batch releases; able to give accurate, succinct updates on particular batch release status.

Alert Supervision of any nonconforming results, out of trend, or out of specification results.

Support supply chain logistics for on time shipment from CMO to Warehouse

Complete and pass all applicable training required for access to the systems

Complete and pass all applicable training for Good Manufacturing Practice and quality requirement training


Bachelor Degree in a scientific function, or equivalent degree level, with minimum of 6+ yr healthcare industry experience

. Experience in quality function in Biologics or Vaccine industry preferred

. Previous experience in work environment under cGMP regulation highly desirable,

Must have strong ability to maintain high efficiencies and accuracy in data entry.

. Strong proof reading skills to validate complex information and detect errors

. Strong quantitative and analytic abilities to analyze and validate data

. Ability to maintain and organized record file is essential

. Strong computer skills in Excel, Word, Sharepoint

. Ability to follow standard operating procedures and work instructions.

. Good interpersonal, communication and organization skills. Ability to manage multiple and changing priorities required.

Detail oriented, dependable and motivated

Willingness to initiative to alert supervision when encountering aberrant data.


**For immediate consideration, please send your resume in a WORD document to**

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

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**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. 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.

Posted: 2020-09-21 Expires: 2020-10-22

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Validations Specialist 3- Manufacturing, vaccines, quality experience a must

Kelly Services
Baltimore, MD 21217

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