Senior Quality Assurance Specialist - Irvine, United States - Kelly Science, Engineering, Technology & Telecom

Description

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:

• Bachelors 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.