Gena Monroy

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 
• 6 years of 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 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

• #HSIR