Document Control Manager jobs in Birmingham, AL

Summary

Coordinates, implements, and maintains the company’s Document Control System. Follows and documents Quality Management Systems within cGMP (21 CFR Parts 11, 210, 211). This may include issuance, filing and copying of, but not limited, to production records, SOPs, Incident Forms, CAPA Forms, Change Control Forms and document control activities while ensuring adherence to company quality standards and FDA guidelines. Strictly follows established procedures and policies needed to meet the demands of document control in a regulated pharmaceutical environment.

Essential Job Functions:

• Performs document control activities.
• Ensures that documents are controlled in a cGMP compliant manner.
• Documenting/Recording information – entering, transcribing, recording, storing or maintaining information in written or electronic format.
• Communication – Communicates with supervisors, peers or subordinates providing information to by phone, in written form, email or in person.
• Following all Good Documentation Practices and cGMP to ensure compliance to applicable FDA guidelines.
• Microsoft Word and Excel
• Meticulous and methodical, with excellent attention to detail.
• Strong organizational skills.

Skilled in:

• Good writing skills.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.

Job Requirements:

• Employee must be honest and ethical.
• Job requires being reliable, responsible, and dependable and fulfilling obligations.

Preferred Qualifications:

• High School Diploma or equivalent