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Senior Quality Assurance Specialist (Validation and Change Control Compliance)

Kelly Services


Location:
Pennsville, NJ
Date:
06/06/2018
2018-06-062018-07-05
Job Code:
US51FPAG_BH1446424
Categories:
  • Engineering
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Job Details

Job Title Senior Quality Assurance Specialist (Validation and Change Control Compliance)

Jobid US51FPAG_BH1446424

Location: Pennsville, NJ, 08070, USA

Description **Senior Quality Assurance Specialist**

**SUMMARY:**

The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions.

**ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES** :


+ Writes and reviews Product Validation, Qualification and Assessment Documents
+ Writes and reviews Equipment Qualifications, and Assessment Documents
+ Writes and reviews Computerized System Validations and Assessment Documents
+ Reviews, evaluates and approves minor equipment changes.
+ Conducts GMP audits and inspections.
+ Reviews lab sample results and manufacturing records relative to qualification/validation activities.
+ Conducts, write, and reviews quality related investigations as appropriate.
+ Responsible for cGMP compliance of assigned manufacturing operations / areas.
+ Conducts environmental monitoring.
+ Reviews and approves DMFs as appropriate.
+ Maintains QA databases for products / equipment as appropriate.
+ Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Code of Conduct.
+ Adheres to all applicable cGMP regulations.
**SUPERVISION:**

N/A

**EDUCATION AND EXPERIENCE:**


+ A BA/BS degree in Engineering preferred, but will consider microbiology, biology, chemistry or the similar
+ 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.
+ Thorough knowledge of cGMP is required.
+ Must have experience with Change Controls and Equipment Validation activies (including dryers, millers, reactors).
**OTHER REQUIREMENTS:**


+ Must have excellent communication skills.
+ Must be conscientious and detail-oriented.
+ Must have excellent computer skills (MS Office, WinLIMS, SAP).
+ Must be a team player.
+ Must be able to self-manage daily work and set priorities.
+ Must be able to manage projects and prioritize appropriately.
**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 relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda 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 connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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