1+ months

Quality Assurance (QA) Specialist III - San Diego, CA

Kelly Services
San Diego, CA 92108
**Quality Assurance (QA) Specialist III, San Diego, CA**

**Position Overview:** Support all activities related to Quality Assurance (QA)

**Essential Duties and Responsibilities:**

+ Supporting all activities related to Quality Assurance as assigned by QA Manager.

+ Managing Change Control (Engineering Changes) system: approving proposed changes, reviewing/approving upon completion.

+ Managing Deviations system: approving initiation, reviewing/approving upon completion.

+ Managing Raw Materials system on QA behalf: approving RMS, managing Materials qualification program, reviewing completed records.

+ Supporting ERP system for Materials Management.

+ Supporting QA Manager with Corrective/Preventive Actions (CAPA) program.

+ Be able to review production and quality control documents for compliance to site procedures and ICH Q7.

+ Supporting Management during regulatory agency and customer audits and visits.

+ Write investigation and deviation reports when requested.

+ Represent with a high level of integrity and professionalism.

+ Adhere to policies and support Management decisions in a positive, professional manner.

+ Other QA related tasks as applicable

**Other Job Duties:**

+ Back up activities of batch records review.

+ Support / back up QA Manger for issuing records and reviewing documentation.

+ Participate and/or conduct Internal and External Audits.

**Job Requirements:**

+ Bachelor's degree (BS) in Chemistry, Biochemistry, or related equivalent experience.

+ 5 years of experience in a GMP regulated industry as a minimum.

+ Excellent communication skills and technical writing skills.

+ Ability to work within the safety guidelines.

+ Good written and oral communication skills; ability to communicate effectively.

+ Accurate typing/keyboarding skills; solid computer skills, including the use of word processing and spreadsheet software applications

+ Knowledge of cGMP.

+ Ability to work independently and as part of a team; ability to motivate self.

+ Ability to work accurately with close attention to detail.

+ Ability to maintain confidentiality of sensitive information.

+ Ability to work with co-workers professionally and tactfully.

**Working Conditions:** Work areas are inside, in a climate-controlled environment with moderate to high background noise.

**Physical Demands:**

+ Sitting/Standing/Walking: Approximately 80% of time is spent seated while working at a desk. Balance of time (approximately 20%) is spent standing or moving around work areas.

+ Speaking/Hearing: Clear diction and acute hearing are necessary for effective communication with co-workers, customers, and outside agencies, by telephone and in person.

+ Vision: Corrected vision close to 20/20 is necessary to effectively use the computer screens and interpret written information.

+ Lifting/Carrying/Pushing/Pulling: The ability to lift and carry up to 25 pounds is necessary for transporting files and office supplies.

+ Stooping/Kneeling: The ability to stoop and kneel is necessary for accessing files/stocking.

+ Reaching/Handling: Good manual dexterity is necessary for computer keyboard use and for retrieving and working with appropriate paperwork, equipment, and supplies.

**For immediate consideration apply today!**

**Questions? Please reach out to Dustin at**

**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: 2020-09-04 Expires: 2020-11-05

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Quality Assurance (QA) Specialist III - San Diego, CA

Kelly Services
San Diego, CA 92108

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