• Kelly Services
  • $100,980.00 -146,790.00/year*
  • Jersey City , NJ
  • Law Enforcement
  • Full-Time
  • 10 Bayside Terrace

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QA Investigations Specialist- Somerset NJ 08873
Temporary position

Reviews, coordinates, and assists to ensure non-conformances are adequately investigated for determination of root cause and product impact per FDA regulations. In addition, ensures that corrective and preventive actions (CAPA) are identified and implemented to prevent/reduce reoccurrence. Oversee product complaint investigation process to ensure they are adequately investigated, within defined timeframes.

Include the following. Other duties may be assigned.
Track all Non-Conformance/Deviation records to ensure the timely closure of all records.
Follow up with the Assigned Tos as needed for status and to ensure support is available to ensure completion by the due date.
Provide SME support on the use of TrackWise workflows to end users as needed.
Provide guidance to Assigned Tos of investigations on performing investigations and in the use of Root Cause Analysis Tools.
Provide guidance and training to other personnel/new hires in the Investigation/CAPA group.
Manage CAPAs to ensure timely closure of actions resulting from various types of investigations.
Provide metrics as requested to track/trend Non-Conformances, Deviations, and CAPAs.
Act as the Investigation Team Lead for Non-Conformance/Deviations investigations as needed.
Perform the closure of Effectiveness Checks.
Manage the Effective Checks to ensure they are completed by the required due date.

Assist during regulatory inspections or other audits as required
Provide training to function areas on compliance issues
Provide training on the use of TrackWise, on performing investigation, and performing root
cause analysis as needed.
Other duties as required

Bachelors degree and a minimum of 8 years experience (preferably sterile products) in a Quality Systems relating to deviations, investigations, out of specifications (OOS), non-lab out of specifications, corrective and preventive actions (CAPA), and product complaints. In addition, experience in performing cGMP related training.

Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
Must exhibit strong organizational, communication, interpersonal skills and attention to detail.
Proficient with computer programs. TrackWise experience preferred.
Five years of previous quality experience in pharmaceuticals or related field.
Preferred experience in sterile product manufacturing as it relates to QA functions such as

Why Kelly ? With Kelly, youll have access to some of the worlds highest-regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll 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 careerconnect 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 with 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 is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
Associated topics: crime scene, detective, fingerprint, inspector, investigate, investigation, investigative, investigator

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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