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Sr Validation Specialist in Maryland Heights, MO at Apex Life Sciences

Date Posted: 12/6/2018

Job Snapshot

Job Description


Apex is seeking a Sr. Validation Specialist for one of our clients in the St. Louis area. If you are interested in learning more please send your updated resume to Lauren Pritts at lpritts@apexlifesciences.com

Essential Functions:

  • Author, review and/or approve cGMP risk assessments, user requirements and functional specifications, validation plans, qualification test protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation efforts as required.
  • Managing and coordinating all aspects of the computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews.
  • Evaluate and advise the system owner with recommendations for appropriate user roles and privileges for data integrity, writing instrument operation instructions and preventive maintenance plans.
  • Ensure 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 and GAMP5 guidelines.
  • Author protocol to challenge the main aspects of regulatory requirements during validation to demonstrate adherence. For systems found unable to fully comply, develop solutions with core stake holders to mitigate the gaps.
  • Act as validation representative for instruments and Subject Matter Expert for Tech Transfers.
  • Partner with Laboratories end-users, System Administrators and the Quality Department on implementation of new instruments.
  • Perform analytical instrument validation which may include, but not limited to, computerized system validation.
  • Provide end-user support for all Quality Laboratory groups as well as maintains compliance to global and site internal policies and procedures.
  • Assist the system owner with evaluating and recommending the appropriate user roles, writing instrument operation instructions, amongst other tasks.
  • Review and approve validation deliverables created by others for adherence to site validation SOPs.
  • Initiate/Review and lead change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software.
  • Initiate and lead risk assessment, gap analysis, and deviation management associated with validation of lab instruments.
  • Complete periodic reviews of cGMP systems, instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state.
  • All other responsibilities as assigned with or without accommodation.

Requirements:

  • Bachelor Degree required in a Science or Engineering related discipline. (Nuclear or Chemical related fields preferred.)
  • 5 to 8 years of experience in the laboratory instrument validation field including those with computerized systems attached in a cGMP environment required.
  • 5-8 years of experience in the pharmaceutical industry or relevant business experience within Quality Control or Validation cGMP Compliance.
  • Experience operating / maintaining instrument systems including Gamma / Alpha Spectroscopy related to Canberra / Mirion Instrumentation preferred.
  • Demonstrated attention to detail, good oral and written communication skills.
  • Must be able to work independently as well as part of a group environment as required.
  • Proficiency with core computer software/systems (Word, Excel, Project, SharePoint, etc.).
  • Demonstrated ability to work in a team environment and manage workload to meet deadlines.
  • Ability to follow instructions in written, oral, diagram, or schedule form.
  • Willingness and interest in learning new skills.
  • Willing to travel.

Working Conditions:

  • Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
  • Must be willing to wear a variety of personal protective equipment.
  • May be required to sit or stand for long periods of time while performing duties.
  • Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
  • Must possess good hand-eye coordination.
  • May be required to work weekends and holidays to support operations.
  • Some gowning may be required to enter laboratory areas.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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