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6 days old

Quality Assurance Coordinator

Kelly Services
Allentown, PA 18103
**Quality Assurance Coordinator**


Allentown, PA


Direct Hire/Hourly


Shift: Monday Friday 2:30pm 11:00pm


**Position Summary:**


Ensure and support quality compliance according to Standard Operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections.


**Essential Duties/Responsibilities:**


+ Perform product inspection for defects, leaks and particulates.

+ Perform environmental monitoring of personnel (as needed) and complete documentation.

+ Assist in the media fill process validations to include inspection of filled units

+ Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets:

+ Verify that raw materials meet specification

+ Verify and account for labeling

+ Review temperature and BMS alarms

+ Verify that product test results meet specification limits

+ Verify that all documentation is complete

+ Document non-compliance and work with supervisor/lead if further investigation is needed

+ Submit samples to the appropriate lab for particulate identification or microbial analysis.

+ Assist with equipment calibration program and maintenance record files.

+ Assist with raw material release and movement.

+ Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.

+ Support internal & external audits.

+ Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).

+ Participate in Quality Managers staff meetings

+ Other duties as assigned


**Qualifications**


**Required:**


+ Minimum of Bachelors degree

+ 0-2 years experience in quality assurance or control


**Desired:**


+ Experience with SOPs or batch records

+ Experienced in aseptic operations.

+ Experience within a regulated environment

+ Degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy.


While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 45 pounds.


**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/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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-02-19 Expires: 2021-03-25

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Quality Assurance Coordinator

Kelly Services
Allentown, PA 18103

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