Document Control Specialist - Birmingham, United States - Biote

Description

Biote Medical is the world leader in hormone optimization and we are adding to our team We partner with providers to take a complete approach to healthier aging through patient-specific bioidentical hormone replacement therapy and the only nutraceutical line created specifically to support hormone health.

We are currently looking for a Document Control Specialist to join our team based in Birmingham, AL. This person must be based on-site in Birmingham.

Overview of Position

A rapidly growing, specialty pharmaceutical company is searching for a Document Control Specialist to generate, issue, and maintain cGMP documentation including Standard Operating Procedures (SOPs), Training Materials, Batch Records, and Protocols. This role will report to the QA Director and will be an individual contributor role.

This position will ensure that the operation of the facility and the equipment are following standards described under Sections 503B of the US Food, Drug & Cosmetic Act, OSHA, environmental, labor, and other governmental laws/regulations, while following appropriate documentation and quality systems.

Essential Duties and Responsibilities

• Create and/or revise SOPs, batch records, and various GMP documents in support of site operations.
• Proofread, merge and format documents upon request using MS Office applications, Adobe programs, or QMS system programs.
• Ensure that documents contain accurate details and instructions corresponding with the activity.
• Coordinate with the training group to ensure appropriate training materials are created with new or revised GMP documentation.
• Adhere to company and global corporate policies and applicable regulatory agencies requirements (ICH, FDA etc.) to ensure documentation compliance.
• Reduce un-necessary redundancy in procedures and GMP documents.
• Perform biennial document reviews and assist in site audits upon request.

Qualifications for Education and Experience

• BS Degree or Associates Degree and/or a minimum of four years related experience in the medical device or pharmaceutical industries.
• Minimum of 2-4 years of technical writing experience in the pharmaceutical/biotechnology discipline or comparable cGMP experience.
• Must have strong organizational and record keeping skills and keen attention to detail.
• High level of computer literacy including MS Word, Excel, Power-Point and Adobe is necessary.
• Ability to work well independently and with minimum or no supervision and identify gaps within documents.
• Ability to work extended and flexible hours (including weekends) when needed.
• Certified Quality Auditor is a plus.

If you're interested in this awesome opportunity, please apply today