18 days old

QA Batch Record Reviewer - Irvine, CA

Kelly Services
Irvine, CA 92604
**QA Batch Record Reviewer** - Irvine, CA

Shift: Mon-Fri; 7AM-3:30PM


+ Review Batch Records (In-Process, Raw Materials and Final Release) for the release of raw materials and components.

+ Review all attachments corresponding to Batch Record (i.e. tickets, charts, spreadsheets, stickers, product colored sheets, check list, MBR, Packaging Reports, Lab Reports, etc.)

+ Generates and disposition product certificates/release documentation (Certificates of Compliance/Analysis) for COS, TX and CA.

+ Responsible for ensuring batch records are complete and all attachments are corresponding Batch Record in a timely manner.

+ Facilitate the release of products by ensuring proper compliance of documentation in a cGMP environment.

+ Support Right First Time Initiatives.

+ Ensure accuracy, integrity and completion of quality documentation and memos.

+ Issue batch records.

+ Issues copies of batch records, OOS, QR, Lab reports, Protocols, Validation Reports, etc. to customers, or Sales department as necessary.

+ Maintain executed batch records (BR) and related documentation

+ Initiate updates to batch records, product specifications, and quality procedures when required via change control.

+ Directly support regulatory inspections, compliance audits and other quality functions.

+ Assist with new product projects.

+ Supply documentation in a timely manner when requested.

+ Create documentation (training, SOPs, etc.).

+ Responsible for keeping complete records of all Batch Records to ensure compliance with established specification and cGMP standards.

+ Responsible for generating CoA and CoC for the finished product that will be sent to the customer as applicable.

+ Work collaboratively with the supervisors and technicians to ensure cGMP procedures are kept current.

+ Assist the QA Manager in conducting Internal Quality Assurance audits.

+ Perform other duties assigned by the Sr. QA Manager to ensure uniform quality assurance throughout the entire company.

+ Other related duties as required.


+ Bachelors degree in a scientific discipline or equivalent combination of education and experience.

+ 5-6 years experience in a quality control or quality assurance function associated with a manufacturing operation, pharmaceutical experience preferred.

+ Good organizational skills and attention to detail

+ Requires good 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 and analyze vague, abstract verbal and written instructions.

+ Ability to apply common sense understanding to carry out instructions.

+ Proficient in; Microsoft Word, Excel, Access, as well as other software packages.

**For Immediate Consideration, Apply Today! Questions?** Call Airika at 562-206-2707 or Email at

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2019-12-30 Expires: 2020-01-30

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QA Batch Record Reviewer - Irvine, CA

Kelly Services
Irvine, CA 92604

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