Senior Quality Assurance Specialist

1 month ago

Irvine, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Science & Clinical is excited to connect you and this Senior Quality Assurance Data Reviewer Position at a Global Leader Pharmaceutical Company in the Irvine, CA Area.

  • 65k-75K/Salary
  • Full time
  • Direct Hire


RESPONSIBILITIES:


  • Review all QC HPLC, GC, CE , AAS. TOC, UV, KF, FTIR and NIR assay and impurity results for Raw Materials, Finished Goods, Stability Products.

  • Monitor all Controlled Products, Raw materials, Standards receiving, usage and inventory.
  • Deacom Time editing for all QC analysts.

  • Assisting Chemist whenever they have some questions on the procedures, analysis and tasks that they are assigned to.
  • Train peers in reviewing all QC data results.

  • Reviews all attachments corresponding to Raw Materials, Finished Goods, Stability Products.

  • Facilitates the release of products by ensuring proper compliance of documentation in a cGMP and GDP environment.

  • Ensures accuracy, integrity and completion of quality documentation and memos.
  • Supports regulatory inspections, compliance audits and other quality functions.
  • Assists with new product projects.
  • Supplies documentation in a timely manner when requested.
  • Assists the QA Manager in conducting Internal Quality Assurance audits.
  • Performs other related duties as required.


QUALIFICATIONS:


  • Bachelor’s degree in a scientific discipline.

  • 6+ years’ experience in a quality control or quality assurance function associated with a manufacturing operation; pharmaceutical experience preferred; or equivalent combination of education and experience.

  • Strong organizational skills and attention to detail.

  • Strong written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.

  • Ability to handle multiple assignments and changing priorities.
  • Ability to learn and utilize computerized systems for daily performance of tasks.
  • Ability to prioritize, manage multiple tasks, and meet deadlines.
  • Ability to understand, read, and write English.

  • Ability to read and comprehend instructions, short correspondence, and memos, policy and procedures.

  • Ability to effectively present information, answer questions, and professionally respond to any concerns in a one-on-one and small group situation.

  • Ability to process, carry out and analyze vague, abstract verbal and written instructions.
  • Proficient in Microsoft Word, Excel, Access, as well as other software packages.

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