27 days old

Quality Lab Supervisor- Edison, NJ 08837

Kelly Services
Edison, NJ 08899
**Quality Systems Supervisor**

**Edison, NJ 08820**


**Required Skills:**

+ Technical writing experience

+ Deviation, investigation, internal and internal audit

+ Batch record, OTC, FDA, GMP

+ Experience working with customers and ability to work in a fast-paced environment

+ Previous supervisory/management experience

+ Preferred skills: cosmetics, pharmaceutical, personal care products

**Job Overview:**

+ Provides management of Quality System activities for site in accordance with clients policies, standards, procedures and cGMPs.

+ This will include USA & Canadian regulatory compliance to the FDA and Health Canada regulations. The job includes organization and maintaining of documentation.


+ Supervises the activities of the Quality Systems group. Ensure compliance with all relevant ISO and FDA GMP regulatory requirements (ISO 22716, 21 CFR Parts 210 and 211)

+ Review and maintain written records and procedures for release.

+ Supervises processes and product through supporting review and approval of change notices and change control. Supervise and support site teams to compile the Annual Product Review summary for OTC product manufactured

+ Lead the customer concern process, collaborating with the manufacturing management team to ensure root cause investigations, corrective and preventive actions, and process documentation are all completed in a timely and thorough manner.

+ Responsible for scheduling and execution of the site internal auditing program assuring CAPAs are completed in a timely manner.

+ Assists team members in the deviation investigation process to completion.

+ Ensures appropriate CAPAs are generated and completed to increase compliance and prevent repeat occurrences of deviations.

+ Writes, reviews and updates SOPs while managing archival of batch records and GMP documentation for the site.

+ Reviewing company practices and providing advice on changes to systems

+ Collaborates with other departments to direct compliance issues to appropriate existing channels for investigation and resolution.

**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: 2020-07-13 Expires: 2020-08-27

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Quality Lab Supervisor- Edison, NJ 08837

Kelly Services
Edison, NJ 08899

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