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18 days old

Quality Assurance Analyst III (BioPharma)- Direct Hire

Kelly Services
College Station, TX 77840
**Quality Assurance Analyst III** **- College Station, TX (** **_Direct Hire)_**



**Kelly Scientific is seeking SEVERAL qualified candidates for multiple DIRECT HIRE QA Analyst III positions have available with a very high-profile Biopharmaceutical R&D/Manufacturing client in College Station, Texas! If you, or anyone you may know, meets the qualifications outlined below,** **apply today or share this opportunity!** **This is a great chance to be a part of a noble cause with a fantastic company with a great work culture. This is a cGMP environment, so experience in this space is highly preferred :)**



**Job Summary:**


The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.



**Preferred Qualifications:**



+ Certified Quality Auditor (CQA)

+ Degree in Biology or Chemistry with several years of QA experience.

+ **_At least 2 years of experience working in a cGMP environment with exposure to good documentation practices._**



**Essential Functions:**



+ Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to:

+ Standard Operating Procedures

+ Batch Production Records (completed and approval)

+ Commissioning, qualification and validation protocols and reports

+ Deviation Reports

+ Corrective Action/Preventive Action Plans

+ Technical data review and approval

+ QC data review and approval

+ Drug Substance/Product Reports

+ Trending QA data

+ Draft and review internal Quality policies, procedures and reports.

+ Perform inspection of final product containers and review and/or approval of executed process records and data.

+ Perform Quality audit functions to include, but not limited to:

+ Audit of lab notebooks

+ Audit of equipment logbooks

+ Review of vendor, supplier, contract laboratory audit questionnaires

+ Lead vendor, supplier, contract laboratory and client audits

+ Identify process and Quality System improvement opportunities.

+ Provide daily guidance for the compliance of the QA department to national and international standards and regulations.

+ Support Regulatory, client, and internal audits.

+ Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.

+ Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

+ Assist with technical oversight/training for the QA team.

+ Assist with compliance related functions.




**Required Skills & Abilities:**



+ **_All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products._**

+ Excellent written and oral communication skills.

+ Excellent organizational, analytical, data review and report writing skills.

+ Ability to set personal performance goals and provide input to departmental objectives.

+ Ability to multitask and easily prioritize your work.

+ Ability to work independently with little supervision.

+ Proficient in Microsoft Excel, Word and PowerPoint.




**Qualifications** **:**



+ Bachelors degree in related science concentration with _6 years experience in Quality Assurance supporting pharmaceutical, biopharmaceutical or biotechnology_ products; OR

+ Masters degree in related science concentration with _4 years experience in Quality Assurance supporting pharmaceutical, biopharmaceutical or biotechnology products._

+ **_At least 2 years of experience working in a cGMP environment with exposure to good documentation practices._**





**APPLY TODAY :)**



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



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-10-09 Expires: 2020-11-09

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Quality Assurance Analyst III (BioPharma)- Direct Hire

Kelly Services
College Station, TX 77840

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