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Senior QA Specialist- Somerset NJ 08873

Kelly Scientific Resources Somerset Full-Time
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Senior Quality Assurance Specialist- Somerset NJ 08873 Requirement: 9248297   Job Overview: Candidate must possess expert knowledge of the cGMPs in the Quality Assurance of oral solid dosage units. Candidate must be flexible, have well-developed organizational skills, and can interact with all levels of management. Candidate must be a self-starter, results-oriented individual with ability to articulate, receive, disseminate, and analyze data.   Job Responsibilities: Manage QA Operations/Plant Quality Assurance programs. Responsible for establishing and maintaining systems to ensure compliance with all applicable regulations. Work with customers having products developed/manufactured at the site in defining Quality systems specific to product or services being rendered. Review and approve master and production batch records. Disposition batches. Support the site program for equipment cleaning verification and equipment usage. Provide oversight for the raw material release program. Author, review and approve site SOPs. Monitor and oversee the DEA Program including manufacturing and analytical activities as per CFR 21 Part 1300 series. Support, Regulatory, DEA, Internal and Customer audits of the facility. Ensure that written responses are provided and appropriately address the observations for customer audits, internal audits, corporate audits, and regulatory inspections and the responses are completed as committed. Manage the Deviation Management Excellence (DME) program for the site. Review and approve Deviations, Non-conformances, Customer Complaints, CAPAs, EOALS, Change Controls, OOS, Atypical/Aberrant and product investigations. Monitor and oversee the CAPA program, trends, findings, and evaluate CAPA effectiveness. Hold regular CAPA meetings with the appropriate departments to ensure completion of CAPAs and their effectiveness. Monitor, assess, and report on Trackwise Problem Reports - CAPA, Change Control, Deviations, Follow-ups, and Tasks etc. by meeting with senior level management team on a regular basis. Ensure that weekly Trackwise meetings are held and that PR owners obtain resolution for open PRs in a timely manner. Ensure that the Trackwise SOPs for all quality systems are current and are being followed by the site as stated. Monitor and oversee Annual Product reviews. Oversee and manage the SSC team including sample/ finished product storage and annual product sample review. Oversee the incoming raw material sampling program. Manage the Compendial Review program Roll out new Compliance programs for the site: creating SOPs and performing training for these programs. Provide department quality metrics and tracker information to Senior Management monthly and upon request. Approve department procedures and assist in the development of new procedures and/or revisions of existing procedures as required. Oversee the Change Control Program ensuring that it meets current regulatory requirements. Contribute to process improvement initiatives and represent QA on project teams, management meetings, and other internal forums. Oversee the Annual Product Reviews. QA Review and approval of protocols, risk assessments, final reports and qualification documents. Participate in customer project meetings, customer complaint meetings, and PR meetings as required. Provide timely and accurate reports and assessments of problems or potential problems to the Director, QA. Maintain responsibility for interpretation and implementation of CGMP¿s and other FDA regulations and pronouncements. Provide staff members with leadership, guidance, mentoring, coaching, and feedback against performance and development objectives. Assign project assignments to staff members with appropriate due dates for project completion. Education:           Education: Candidate must have a BS degree in Chemistry, Microbiology, Pharmacy, or related Science. A Bachelor’s degree with appropriate experience in the Pharmaceutical Industry is desired. Master’s degree is preferable.   Experience:   Minimum of five (5) years of experience working in Quality areas in the pharmaceutical industry with progressive management responsibilities. Experienced working in a cGMP management role with an understand of compliance and DEA regulations. Knowledge:          Full understanding of FDA and EU CGMPs and DEA regulations pertaining to clinical trial and commercial activities. Good understanding of statistics and audit techniques. Must be well organized and can multitask. Thorough knowledge of CGMPS, ability to evaluate facilities records, processes, procedures and practices for conformance to these requirements. Good mathematics skills. Good Computer skills, including in depth knowledge of MS Office software package. Safety procedures associated with the department. Read and understand MSDS requirements and restrictions. Understand procedures related to Document Control, Quality Assurance and this job function. Requires a good understanding of drug manufacturing and laboratory operations. Experience with performing CGMP audits.  





Why Kelly®?


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.



About Kelly Services®


As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit URL blocked - click to apply and connect with us on URL blocked - click to apply, URL blocked - click to apply and URL blocked - click to apply.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. URL blocked - click to apply

 

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In a recent study, one-third of large companies predicted contingent workforce growth of 50 percent or more.* Kelly Scientific Resources® can help you be a part of this contingent workforce growth opportunity.

Kelly Scientific Resources is a specialty service of Kelly Services®. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines, including:

  • Biomedical
  • Biotechnology
  • Chemical
  • Clinical Trials / Clinical
  • Clinical Research
  • Consumer Products
  • Cosmetics
  • Drug Discovery and Safety
  • Environmental Health
  • Food Science
  • Health Physics
  • Laboratory
  • Pharmaceutical
  • Production and Manufacturing
  • Quality Assurance and Control
  • Research and Development

Kelly Scientific Resources employees work more than 7 million hours in positions ranging from clinical research associates to molecular biologists to biochemists—from entry level to Ph.D.

It all began when William R. Kelly—founder of the temporary staffing industry—established Kelly Services® in 1946. The company's traditional expertise started with office services, call center, light industrial, and electronic assembly staffing. Through the years, we expanded our expertise and established a proven record of successfully matching job seekers to opportunities in disciplines such as science, engineering, law, education, healthcare, IT, and finance. As a Fortune 500® company, Kelly® has evolved into a global workforce solutions leader, making employment connections for nearly half a million people around the world every year.

Since our founding, we have embodied the true spirit of social responsibility. Our character and values resonate through our culture. Inherently—through our core business focus—we seek to improve the quality of life for our employees, their families, and their communities, as well as society at large. We embrace the role we play and the value we contribute to society—whether ensuring equal opportunity to employment, promoting safer workplace conditions, advocating for healthcare reform, or adhering to sustainable business practices.

Together with our employees and our customers, we will continue to work toward ensuring that our legacy will remain strong for generations to come. For more than 60 years, people have trusted Kelly Services to help them reach their career goals. We are your proven link to employment opportunities that will pave the way for a successful future. Whoever and wherever you are—and with the right skills and attitude—Kelly can help you find a job, expand your career, and build your future.

*According to “The Emerging New Workforce,” a 2009 report by Littler Mendelson, P.C., an employment and Labor Law solution firm.

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