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15 days old
**Quality Assurance Supervisor**
2nd Shift: 2:30pm-11:00pm
Bloomsbury NJ
Permanent/Salaried
**Position Overview:**
Responsible for supervising all Quality Assurance (QA) aspects of compounding pharmaceuticals for compliance within the sterile production facility. Operates within the legal and regulatory compliance, producing a quality product. Operates the area as the supervisor over the QA operations/staff, coordinating day to day functions.
**Responsibilities may include** :
+ Supervises Quality Assurance staff on assigned shift
+ Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions
+ Develops and provides oversight to identification and implementation of appropriate corrective actions and preventive actions
+ Oversight of the environmental monitoring program including appropriate escalation of environmental and personnel monitoring results that exceed alert or action limits and interpreting results.
+ Responsible for timely and accurate disposition of finished product to assure each batch meets specification prior to release
+ Periodically review records to verify that quality standards for each drug product is met
+ Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
+ Responsible for maintaining QA records associated with internal and external testing
+ Responsible to maintain all testing equipment in compliance, calibration and certification
+ Assists in developing policies and procedures related to QA
+ Promptly communicates with Operations regarding complaints, product issues/variance
+ Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
+ Enforces applicable personnel policies and procedures
+ Performs other duties as assigned by Management
**Qualifications:**
+ Legally authorized to work in the job posting country
+ High school Diploma or GED from recognized institution or organization required
+ Bachelors Degree in Life Science or other related field preferred
+ 1 year of supervisory or management experience required
+ 2 years experience in Quality Assurance / cGMP / FDA regulated industry
**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)
2nd Shift: 2:30pm-11:00pm
Bloomsbury NJ
Permanent/Salaried
**Position Overview:**
Responsible for supervising all Quality Assurance (QA) aspects of compounding pharmaceuticals for compliance within the sterile production facility. Operates within the legal and regulatory compliance, producing a quality product. Operates the area as the supervisor over the QA operations/staff, coordinating day to day functions.
**Responsibilities may include** :
+ Supervises Quality Assurance staff on assigned shift
+ Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions
+ Develops and provides oversight to identification and implementation of appropriate corrective actions and preventive actions
+ Oversight of the environmental monitoring program including appropriate escalation of environmental and personnel monitoring results that exceed alert or action limits and interpreting results.
+ Responsible for timely and accurate disposition of finished product to assure each batch meets specification prior to release
+ Periodically review records to verify that quality standards for each drug product is met
+ Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
+ Responsible for maintaining QA records associated with internal and external testing
+ Responsible to maintain all testing equipment in compliance, calibration and certification
+ Assists in developing policies and procedures related to QA
+ Promptly communicates with Operations regarding complaints, product issues/variance
+ Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
+ Enforces applicable personnel policies and procedures
+ Performs other duties as assigned by Management
**Qualifications:**
+ Legally authorized to work in the job posting country
+ High school Diploma or GED from recognized institution or organization required
+ Bachelors Degree in Life Science or other related field preferred
+ 1 year of supervisory or management experience required
+ 2 years experience in Quality Assurance / cGMP / FDA regulated industry
**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: 2021-01-11 Expires: 2021-02-25
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