Kelly Services Aseptic Compliance Auditor - Pharma - Texas in Sugar Land, Texas

Kelly Services is currently seeking a DIRECT HIRE Aseptic Compliance Auditor for an esteemed client located outside of Houston, TX within the Baytown metropolitan area. The cGMP Aseptic Compliance Auditor will be responsible for conducting independent internal aseptic behavior and technique audits to ensure all operations remain compliant with governing standard operating procedures, regulatory requirements, regulatory commitments and the FDA’s cGMPs requirements.

They will independently perform Pharmaceutical Aseptic Monitoring and oversee the aseptic activities of Pharmacists charged with the responsibility of ensuring cGMP-compliant aseptic processing of Pharmacy Technicians (and cleanroom support personnel) across all production shifts at all compounding facilities.

DIRECT HIRE + BENEFITS + RELOCATION + BONUS ELIGIBLE

Candidate MUST Have:

  • Working knowledge and understanding of 21 CFR 210, 211 cGMP regulations, U.S. Pharmacopeia (USP) as well as salient FDA Guidance for Industry

  • Knowledge of Part 11 and data integrity compliance

  • 5 + years of external regulatory audit, compliance remediation and internal GMP audit experience

  • 5+ years of specific pharmaceutical GMP experience required

Responsibilities:

  • Aseptic Behaviors and Training Monthly gowning recertification and Monthly media fill requalification

  • Implement new policy and process changes on cleanroom expectations and progressive discipline Perform sterility test samples

  • Environmental and Personnel Monitoring testing in ISO 5 environment on a per batch basis with results required prior to batch disposition and release

  • Maintain batch record documentation requirements inclusive of all activities and components used

  • Facility cleaning enhancements

  • Component preparation and sanitization

  • Daily multi-point weight checks for all production and laboratory balances

  • Specific SOPs to monitor for compliance

  • CPS-313, “Aseptic Technique and Classified Area Management”

  • CPS-303, “Operation of Laminar Flow Clean Benches”

  • CPS-307, “Clean Room Air System Operation and Monitoring”

  • CPS-707, “Microbiological and Environmental Testing”

  • CPS-701, “Employee Aseptic Processing Qualifications and Requalification”

  • CPS-042, “Partnership in Compounding Excellence”

  • CPS-311, “Component Sanitization prior to Clean Room Entry”

  • CPS-715 “Critical Systems”

  • Escalate objectionable cGMP practices to Legal & Compliance management

  • Prepare and communicate a weekly summary of the compliance state of the facility operations, identification of any non-compliance conditions, adequacy of investigations performed by the facility and any additional training needed for facility personnel.

  • Perform any needed follow-up activities including investigations and audits on an as-needed basis

  • Provide identified quality metric data for Compliance Program Review meetings (monthly, quarterly)

Qualifications:

  • BS/Advanced degree in Microbiology or Physical Sciences

  • 3+ years demonstrated expertise in laboratory and manufacturing investigations

  • Familiarity with aseptic processing environmental monitoring and cleaning, strongly preferred.

  • Ability to use scientific principles/process/regulatory knowledge to identify critical compliance issues

  • Interact and communicate with Sr. Management effectively

  • Effective verbal and written communication skills

  • Ability to provide guidance and resolve conflicts

Benefits:

  • Medical, Dental, Vision, Life Insurance

  • 401k

  • Employee Stock Purchase Program

  • Tuition Reimbursement Plan

Apply Today for Immediate Consideration!

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—

providing you with opportunities to work on today’s most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.