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15 days old

Sterility Assurance Manager - Bloomsbury, NJ

Kelly Services
Bloomsbury, NJ 08804
**Sterility Assurance Manager - Bloomsbury, NJ**


**Position Overview:**


+ Responsible for managing all Quality Assurance and Quality Systems departments supporting all aspects of compounding sterile pharmaceuticals and regulatory compliance within the facility.

+ Operates within the legal and regulatory compliance, producing a quality product.

+ Operates the area as the manager over the QA and QS staff, coordinating roles & responsibilities and projects.


**Responsibilities may include:**


+ Manage QA & QS supervisors by providing learning and development where appropriate

+ Ability to make Quality decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations

+ Manages the on-time release of batches Manages the on-time initiation and closure of Deviations / Investigations, CAPAs, Change Controls with thorough & standardized supporting documentation

+ Manages others to ensure appropriate SOPs and training documents are in place & effective

+ Manages others to ensure the design and maintenance of the environmental monitoring program including environmental and personnel monitoring are adequate and in place

+ Manages others to ensure QuVa quality standards are met at the site so that processes are the same as other QuVa sites

+ Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws

+ Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities

+ Manages others to maintain site documents supporting the commercial manufacturing & release of sterile injectable products

+ Manages the design and implementation of site policies and procedures

+ Escalates to VP of Quality critical issues jeopardizing manufacturing & release of a safe & effective product that meets regulatory requirements

+ Promptly communicates with Operations regarding complaints, product issues/variances

+ Enforces applicable personnel policies and procedures

+ Other duties as assigned


**Qualifications:**


+ Bachelors Degree in Life Science or other related field

+ 5-7 years prior experience in a Quality/ cGMP / FDA regulated industry

+ Minimum 5 years of supervisory or management experience required

+ Experience with aseptic techniques and appropriate gowning techniques supporting manufacturing of sterile injectable products

+ Technical writing and communication

+ Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMPs and have demonstrated strength in problem solving and resolution

+ Strong interpersonal skills


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Dustin at DUSG877@kellyservices.com_**


**_\#TJP2021_SPEC_**


**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 (plus, did we mention we provide a ton of benefits ?). 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)
Posted: 2021-10-01 Expires: 2021-11-01

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Sterility Assurance Manager - Bloomsbury, NJ

Kelly Services
Bloomsbury, NJ 08804

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