Job Abstract

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.

Please quick Apply, A Kelly Recruiter will contact you

Thank you,

P1#9362435

9362435