Document Control Assistant - 2nd Shift

Amneal Pharmaceuticals; Town of Brookhaven (NY); On-site; USD 24,796 - 30,307; Full time

Benefits offered by this job

Health insurance

401(k) matching

Job summary

A leading pharmaceutical company is seeking a Document Control Assistant for the 2nd shift in Wyandanch, NY. The role involves managing document control processes, ensuring compliance with regulations, and collaborating with various teams. Candidates should have a high school diploma, with an associate degree preferred, and less than a year of manufacturing experience. Compensation ranges from $18.00 to $22.00 per hour, along with competitive benefits like health insurance and 401(k) matching.

Qualifications

• High School diploma or GED required.
• Associate degree preferred.
• Less than one year of experience in manufacturing.

Responsibilities

• Manage document control processes through electronic systems.
• Distribute approved documentation to appropriate personnel.
• Collaborate with departments to ensure documentation compliance.
• Prepare documentation for inspections and audits.

Skills

QA Documentation

cGMP

MS Word

MS Excel

MS Access

Multitasking

Flexibility

Education

High School or GED

Associate Degree

Tools

Document Compliance Systems

Job description

Document Control Assistant - 2nd Shift

Amneal Pharmaceuticals

Location: Wyandanch, NY

Schedule: 2nd Shift, 3:30 pm – 12:00 am, Monday to Friday

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 thru electronic systems and/ or paper base systems. Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks.
• Maintaining 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, maintain an up-to-date Document Control Systems.
• Store, archive, and retrieve the version documents such as certificate 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.
• Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks. Track document approvals and any related activities and ensure on-line 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 for 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 $18.00 to $22.00 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 helps you enjoy your career alongside life’s many other commitments and opportunities.

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.