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18 days old

Quality Assurance Associate Scientist- Somerset NJ- Permanent Position

Kelly Services
Somerset, NJ 08873
Quality Assurance Associate/QA Scientist- Permanent Position


Somerset NJ 08873


Core Skills:


+ Responsible for the oversight of the QA program and the QMS at the site level.

+ Conduct a continuous review of aseptic operations to ensure compliance to internal procedures (gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.

+ Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.

+ Knowledge of USP, FDA, and cGMP regulations preferred.

+ Knowledge of how and ability to write, review, and revise SOPs required.


Essential Duties and Responsibilities:


+ Maintain oversight of the QA program and Quality Management System (QMS) at manufacturing facility producing products under both 21 CFR Part 212 and 211.

+ Apply QA processes and procedures at the site level to ensure product quality and regulatory compliance. Write, review, approve, and implement procedures, specifications, processes, and methods as required.

+ Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.

+ Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.

+ Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site. Liaise with internal and external inspectors and representatives, particularly on QA-related topics. Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).

+ Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify to management problems in personnel, equipment, and the facility that requires correction.

+ Review documents associated with the sites QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality.

+ Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.

+ Ensure any deviations from normal procedures are documented and justified.

+ Ensure an investigation is performed and documented when required and CAPA are taken (i.e., follow and maintain corporate CAPA, deviation, and OOS protocols).

+ Ensure compliance with all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.

+ Ensure product complaints are handled in a manner consistent with Company SOPs and FDA regulations. Responsible for opening change controls and initiating, maintaining, and reviewing site-specific procedures relative to their job functions.

+ Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented. Attend quality and operational meetings.


Qualifications:


+ B.Sc. preferred, Biology, Chemistry, Biotechnology, Biochemistry or related field

+ Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.

+ Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.

+ Ability to write reports, business correspondence, and procedure manuals required.

+ Ability to effectively present information, deliver training and respond to questions from groups of managers, clients, customers, and the public required.

+ Ability to define problems, collect data, establish facts and draw valid conclusions required.

+ Proficient in MS Office applications required. Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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)

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Posted: 2022-06-10 Expires: 2022-07-11

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Quality Assurance Associate Scientist- Somerset NJ- Permanent Position

Kelly Services
Somerset, NJ 08873

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