Job Description
Job Title: Sr. Quality Assurance Specialist Reviewer ( Immediate Need)
Sr. Quality Assurance Specialist Reviewer Pay rate: $75,000
Sr. Quality Assurance Specialist Reviewer Hours : 1st Open to start time Monday-Friday
Sr. Quality Assurance Specialist Reviewer Start Date : ASAP
A Pharmaceutical Manufacturer in Irvine has an opportunity for an upbeat and positive Sr. Quality Assurance Specialist Reviewer reporting to the Quality Assurance department.
Sr. Quality Assurance Specialist Reviewer Responsibilities:
Assists the QA Manager in conducting Internal Quality Assurance audits.
Supplies documentation in a timely manner when requested.
Review all QC HPLC, GC, CE , AAS. TOC, UV, KF, FTIR and NIR assay and impurity results for Raw Materials, Finished Goods, Stability Products.
Facilitates the release of products by ensuring proper compliance of documentation in a cGMP and GDP environment.
Reviews all attachments corresponding to Raw Materials, Finished Goods, Stability Products.
Monitor all Controlled Products, Raw materials, Standards receiving, usage and inventory.
Decomposition Time editing for all QC analysts.
Assisting Chemists whenever they have some questions on the procedures, analysis and tasks that they are assigned to.
Train peers in reviewing all QC data results.
Ensures accuracy, integrity and completion of quality documentation and memos.
Supports regulatory inspections, compliance audits and other quality functions.
Assists with new product projects.
Performs other related duties as required.
Sr. Quality Assurance Specialist Reviewer Requirements:
Bachelor’s degree in a scientific discipline
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 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
Ability to understand, read, and write English