Quality Assurance Auditor - QA Release

Catalent

Morrisville,NC  

2019-10-03 2019-11-02
quality administration pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



Job Description

Position Overview:



Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here











This employee will report directly to the QA Group Leader







Overview



As an entry level position, the auditor is able to perform routine auditing of pharmaceutical projects, using established procedures. This position requires moderate independent judgment with direct supervision. The work is routine and well defined. Discuss actions to be taken with supervisor before resolving issues. As an experienced position the auditor can work under general supervision and is able to perform more complex auditing of pharmaceutical projects and systems using established procedures. Independently performs routine work with progressively more involvement in recommendations for the improvement of the department. Subsequently, may require direct supervision under non-routine circumstances. Will make judgments on observations with limited supervisory review. Position requires some degree of initiative to resolve problems. The work is routine to moderately complex but covered by well-defined policies and procedures. Discusses actions to be taken before resolving routine problems. Comply with divisional and site Environmental Health and Safety requirements.







The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.







The Role





+ Audit a variety of methodologies as applied to various stages of pharmaceutical development.



+ Verify accurate transcription of raw data into reports.



+ Audit above testing for compliance to all applicable SOPs and regulatory requirements.



+ Discuss issues with lab staff as discovered during final report auditing, laboratory walkthroughs, or other internal audits.



+ Archive study phase documentation in a timely manner.



+ Identify potential compliance issues and takes corrective measures to prevent them, participating on assigned teams as required.









The Candidate





+ Bachelor’s degree in chemistry or closely related physical science from a four-year college/university or equivalent education and job experience with 1-2 years of related experience and/or training



+ The employee must have a good understanding of chemistry/lab practices and be able to function independently with supervision



+ Good communication and organizational skills are required



+ Requires knowledge of cGMP, GLP, ICH, and USP regulations or guidelines



+ Requires contact with multiple departments and on occasion with customers



+ Must have previous experience with analytical QA Release and batch record review



+ Usually supplies and seeks information where exceptional tact and courtesy is needed









Position Benefits





+ Medical, Dental, Vision and 401K are all offered from day one of employment



+ 19 days of paid time off annually + 7 paid holidays









Leadership Competencies for Performance and Development





+ Leads with Integrity and Respect



+ Delivers Results



+ Demonstrates Business Acumen



+ Fosters Collaboration and Teamwork



+ Champions Change



+ Engages and Inspires



+ Coaches and Develops









Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.







personal initiative. dynamic pace. meaningful work.Visit www.catalent.com/careers to explore career opportunities.











Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.







Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.





Catalent = Catalyst + Talent







Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!







personal initiative. dynamic pace. meaningful work.







Catalent is the perfect place to grow your career if…





+ You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).











+ You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!











+ You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.











+ You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.











+ You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!











+ See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.











Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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