23 days old

Quality Assurance Specialist - CAP/CLIA/GCP

Kelly Services
Morrisville, NC 27560
Kelly Scientific is seeking a **Quality Assurance Specialist** for a **Direct Hire** Opportunity in Morrisville, NC. The individual in this role is heavily involved with QA systems, study management, operations, audits, inspections and other areas, as directed under the supervision of the Director of QA/RA.

Essential Duties and Responsibilities:

+ Manage document control process through MasterControl. Track Standard Operating Procedures (SOPs), forms, and other regulated documents to ensure timely and accurate review and content.

+ Ensure that all SOPs are written in accordance with applicable regulatory statutes, standards and guidances.

+ Recommend, create, implement, and update SOPs, as necessary, to improve processes, and support compliance.

+ Support the maintenance of study related and/or study support files.

+ Notify technical staff of appropriate regulatory requirements required to conduct such roles.

+ Conducts internal and external audits/inspections as required and maintain/ update documentation governing the activity.

+ Performs qualification and periodic audits of contracted vendors as requested or indicated.

+ Act as a Quality Assurance representative, as designated by the Director of QA/RA, to oversee operative related tasks, including but not limited to, the activity, resultant impact and/or risk mitigation mechanism required to ensure operations are conducted in accordance with regulatory statutes and CGI policies and procedures.

+ Support senior QA personnel in related tasks and operations as applicable and indicated.

+ Conduct necessary evaluations and assessments of the QMS as it pertains to continuous improvement and the closure of any GAPs derived based on the assessment results obtained therein.

+ Ensures that metrics established (Key Performance Indicators KPI, Quality Indicators QI, and/or thresholds, etc.) for departments and operations are maintained and that any deviations and/or excursions outside of such metrics are remediated appropriately and monitored.

+ Support Quality Event activities, such as Deviations, Corrective and Preventative Action (CAPA) operations, etc. and ensure such is conducted effectively, efficiently and in accordance with applicable regulatory requirements and standards

+ Conduct Root Cause Investigations/Assessments (RCI or RCA) as applicable to investigate any quality events observed throughout the organization and/or on a study specific basis.

+ Provide support to the QA team during regulatory agency inspections or third-party audits by participating in inspection preparation and assisting the inspection strategy room.

+ Provide support to the team with any validation operations.

+ Responsible for maintaining certification/accreditations/licensures records for the laboratory.

+ Oversee the organization and maintenance of all laboratory binders.

+ Oversee laboratory activities and support lab departmental heads in assuring that all technical operations are conducted in accordance with applicable regulatory requirements and documented evidence of such is in accordance with GxP and are ALCOAC.

+ Support and ensure that the QMS and any company related events and/or optimization mechanisms follow the PDCA cycle.

+ Contribute to the team effort by accomplishing related duties as needed.

**Education / Experience:**

+ Bachelors degree in biology, chemistry, biochemistry, medical terminology or scientific discipline

+ Minimum 2 years of lab bench experience

+ Minimum 2 years in GLP / GCLP quality assurance (QA)

+ Experience in working in biotech, pharmaceutical, CRO / CMO or similar organization


+ Internal and/or GxP auditing experience

+ Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner

+ Excellent oral and written communication skills

+ Proficient in MS Excel and Word

**Apply today for immediate consideration!**

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

Kelly Science 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. 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. at
Posted: 2020-05-11 Expires: 2020-06-11

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Quality Assurance Specialist - CAP/CLIA/GCP

Kelly Services
Morrisville, NC 27560

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