Lab Instrument Validation Consultant job Nashville North Carolina
Lab Instrument Validation Consultant job Nashville North Carolina
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Lab Instrument Validation Consultant Job



Employer Name: SpiderID: 8611010
Location: Nashville, North Carolina Date Posted: 5/1/2019
Wage: Negotiable Category: Medical/Health
Job Code: BBBH29504

Job Description:

Job Summary
Our Client, a research-based pharmaceutical company, is seeking a Lab Instrument Validation Consultant possessing the below qualifications:



  • Validation of laboratory instruments including those with computer system attached for instrument control (i.e. AA, FT-IR, ICP-MS, TOC, UV_Vis)

  • Experience with configuring, testing and validating the laboratory systems to demonstrate compliance with 21 CFR Part 11/Annex 11 as well as proposing procedural controls if the system is unable to fully meet the requirements

  • Hands on experience operating the instrument systems to be able to write test scripts to demonstrate the essence of the Part 11 regulations which is to ensure that electronic records and signatures are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. As such, the electronic records should not be susceptible to unauthorized access, alteration/modification, deletion, or other methods of falsification and the audit trail must capture changes. These records need to be accurate and be accessible/available for the duration of data retention period in case it is needed for regulatory or other audits.

  • Must be able to multi-task - new/multiple projects will be thrown at the worker constantly, must be able to handle all of them.

  • Detail oriented is required!


Responsibilities



  • Serves as validation representative for laboratory instruments and partners with the laboratories, Quality System Administrators, Business Technology, Instrumentation and Quality Engineering on implementing new instruments at the site.

  • Initiates and leads risk assessment, gap analysis and deviation management for commissioning of, changes to or decommissioning of laboratory instruments and associated instrument control software where applicable within the Quality Laboratories.

  • Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs.

  • Ensures lab instruments adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines. Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence. For systems found unable to fully comply, formulate workarounds/strategies with core stake holders to mitigate the gaps.

  • Assists the system owner with evaluating and recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and setting up preventive maintenance plans.

  • Previous experience with Trackwise PR/CAPA systems preferred.

  • Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.

  • All other duties as assigned.


Qualifications
Education



  • Bachelor's degree in a science or engineering related discipline with knowledge of quality operations laboratory processes.


Experience



  • 3-5 years of experience in the validation of laboratory instruments including those with computerized systems attached in a biotechnology or pharmaceutical cGMP manufacturing environment

  • Hands on experience validating various laboratory instrument systems (e.g. PerkinElmer AA, FT-IR, Climet CI-150t, IC, Agilent ICP-MS, Instron 5965, Keyence IM-7030, SmartScope Flash 500, TOC, UV_Vis)

  • Demonstrated expertise in identifying as well as formulating procedural controls to compensate for shortcomings in the systems data integrity and FDA 21 CFR Part 11 controls.

  • Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements.

  • Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices

  • Ability to manage multiple activities and constantly change priorities.

  • Exposure to lab operations and scientific processes associated as well as familiarity with a variety of laboratory instruments with various areas (Chemistry, Micro, Biological, EM etc.)

  • Strong critical thinking and problem solving skills.




Please submit your resume for consideration. Once submitted, feel free to contact Michael at 347-522-1095 for additional information.

Approx. Duration: 12 months

About Hired By Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.

We work hard to match our candidates with the right career opportunities. Let us find you a #MatrixMatch so you can reach your career goals!

Connect with us on LinkedIn and see how we can impact your career!

Hired by Matrix Career Center: https://www.hiredbymatrix.com/find-work/open-positions/



Job Criteria:
Start Date:
Position Type: Contractor
Years of Experience Required:
Education Required:
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Contact Information:
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Company: Hired by Matrix, Inc.
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