Overview
Document Control Assistant – 2nd Shift Jobs in Brookhaven, New York, USA at Amneal Pharmaceuticals LLC (J0P) in
Location: Brookhaven
Document Control Assistant – 2nd Shift (Administrative)
Description:
The document control specialist is responsible for administering the processes and practices which support documentation compliance. The Specialist will work in a pharmaceutical production facility and in close collaboration with Quality Assurance, Quality Control and Production with a key focus on documentation accuracy, quality and integrity.
Essential Functions:
Manage document control processes through electronic systems and/or paper-based systems. Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks.
Maintain lists and postings required for both electronic and hard copy; maintain specific databases in Document Control Department and training records.
Perform data entry and management in systems (Document Compliance and Process Compliance) and maintain the print/soft copies for all documents.
Collaborate with teams to complete and maintain an up-to-date Document Control System.
Store, archive, and retrieve version documents such as certificates of analysis of materials and products, specifications, methods, protocols, and report files.
Prepare and distribute PBRs, Packaging Batch Records, SOPs, methods and protocols, and other controlled documents.
Track document approvals and any related activities and ensure online documents are updated and accurate.
Work with other departments to clarify and correct documentation to ensure compliance.
Organize and maintain the work area and keep up-to-date files.
Additional Responsibilities:
Prepare documentation for third-party inspection/audits.
Assist validation and regulatory department for documentation and their various requirements.
Education:
High School or GED – Required
Associate Degree – Preferred
Experience:
Less than one year in manufacturing.
Skills:
2 years of QA Documentation – Intermediate
cGMP and computer skills (MS Word, Access, and Excel) – Advanced
Multitasking and flexibility to accommodate changing priorities – Advanced
Specialized Knowledge:
cGMP, Computer Skills (MS Word, Excel, Access)
The hourly base salary for this position ranges from $20.00 to $25.00 per hour. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to qualifications, geographic location, and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible, and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement.
We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
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Title: Document Control Assistant – 2nd Shift
Company: Amneal Pharmaceuticals LLC (J0P) in
Location: Brookhaven, New York, USA
Category: Administrative/Clerical, Quality Assurance – QA/QC
