Quality Assurance Documentation Associate Job

QUALITY ASSURANCE DOCUMENTATION ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in MELVILLE, NY.

WHAT YOU'LL BE DOING:

- Compile and Issue BRFs to ensure that all documents such as Manufacturing Instructions (MIs), Filling Instructions (FIs), and/or approved Validation Protocol(s) inserted in BRFs are current and accurate in accordance with the Dispensary, Hicksville and Melville Fill schedules provided by the Planning Department Collaboration with Planning to determine priorities on BRFs and schedule changes to meet business needs Partner with Validation and MS&T personnel
- Generate BRFs needed to support validation and noncommercial activities to include but not limit to, obtain the approved protocols, deliver the Finished BRFs to Stability Group for stability assessment Utilize Documentum for batch-printing of MIs, or FIs, and control-printing of Validation Protocol for BRFs issuance Archive/Retrieve the executed BRFs in a timely manner.
- Scan/File the executed BRFs in a shared folder Maintain Document archival room in a manner to ensure documents are securely stored, controlled and accounted for and in accordance with company policies Assist other functions within Quality Assurance Documentation Group as deemed necessary
- Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
- Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.

WHAT YOU NEED TO BRING TO THE TABLE:

- Associate Degree or equivalent at a minimum
- Minimum of one to two (1-2) years of pharmaceutical industry experience preferable in a Quality Environment
- Able to read English well
- Must have knowledge of cGMP's and SOP's
- Well organized, works well in a team environment
- Able to adapt to changing priorities
- Good Knowledge of an EDMS system, Documentum a plus
- Good communications (verbal and written) skills
- Good mathematical skills
- Attention to detail and good proof reading skills a plus.
- Good working knowledge of Microsoft Outlook, Word and Excel computer programs
- Able to lift a box full of executed BRFs (approximately 40 - 50 lbs)

WHAT'S IN IT FOR YOU?

- This is a wonderful opportunity for you to play an integral role at a growing site within one of the largest and most respected pharmaceutical companies in the world.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Kathy Pavlick

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Contact us if you are an individual with a disability and require accommodation in the application process.

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