Senior Quality Assurance Specialist
1 month ago
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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