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Patheon
QA Analyst, Records Release
Cincinnati, OH - USA
Posted January 02, 2018

Join us as We Transform How Pharmaceuticals are Made.

Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
Summary
TITLE: QA Analyst-Records Release

Duties & Responsibilities:

Incumbent expected to approve/reject batch records based on review of documentation. The job also involves preparation and review of Certificates of Analysis (COAs) as well as interacts with Clients concerning batch record review and approval.   The work environment  consists of constantly changing priorities and tasks; therefore, the individual must work efficiently and be flexible in order to meet release and ship dates.   Must be able to work in a team environment and support multiple team members in addition to maintaining assigned tasks.  Some off-shift work may be required as well as being able to work on the shop floor as needed.   Job requires daily interaction with PMQA, PDS, GMP Services, Quality Assurance, Quality Control, Planning, Manufacturing and Packaging. 



Key Requirements
The job requires attention to detail, good organizational skills, and good written and verbal communication skills. Familiarity with various LIMS and SAP functions is preferred.  Must have a sound understanding of Quality Assurance and Manufacturing.  Responsible for BPR and LPR filing, storage and retrieval. Ensures work is performed in accordance with approved methods   
Qualifications
Requirements:
AT LEAST 3 YEARS OF EXPERIENCE IN QUALITY ASSURANCE, QUALITY CONTROL OR OPERATIONS.  MUST HAVE A GOOD WORKING KNOWLEDGE OF CGMPS, AND FDA REGULATIONS.  MUST HAVE GOOD VERBAL AND WRITTEN COMMUNICATION SKILLS. MUST BE CAPABLE OF USING WORD PROCESSING, SPREADSHEET PROGRAMS AND LIMS.  MUST BE ABLE TO MANAGE AND PRIORITIZE DAILY TASKS WITH MINIMAL SUPERVISION.

Bachelor’s degree in Pharmacy, Chemistry, Engineering or other related Scientific Majors preferred.  Non-degreed candidates with a minimum of 5 years successful performance in relevant areas of Operations or Quality will be considered.


Help Us Make a Healthier World.

Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
Disclaimer

Patheon is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 
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