Document Control Supervisor
Direct and perform all cGMP document control functions for all NorthStar locations including tracking, processing, distributing, and archiving.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Oversee and administer NorthStar’s electronic documentation system.
2. Examine and coordinate documents such as bills of materials, blueprints, drawings, release notifications, and specifications to verify completeness and accuracy of date, and facilitate data entry.
3. Follow the procedures to archive completed/obsolete documents
a. Batch Production Records (BPRs)/Master Batch Records (MBRs)
c. Obsolete versions of controlled documents
4. Facilitate ANDA/NDA submissions by providing relevant documents to Regulatory Affairs and any related response to FDA queries.
5. Ensure document control metrics are collected, reviewed, and actionable. Report document control metrics to Manager, Quality Assurance.
6. Direct and assist with printing of Batch Production Records (BPRs) and Labels for Operations.
7. Administer the change control process from issuance to closure
a. Compile and proof files provided by the originators into a change control package
b. Route each change control package and gather approval signatures
c. Transition from routing to approved to effective to allow adequate time for new document/revision training
d. Perform change control trending
8. Assist document originators to resolve discrepancies and compile required changes to documents.
9. Issue laboratory notebooks.
10. Create and/or update work instructions, procedures, reports, and other documents as assigned.
11. Review, revise, and/or standardize documentation written by others.
12. Ensure direct reports remain current on training.
13. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
14. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.
Ability and willingness to travel up to 20% of the time between facilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Associate’s Degree in a scientific discipline and three or more years of experience in technical document administration in the pharmaceutical industry; or equivalent combination of education and experience. Working knowledge of pharmaceutical manufacturing processes 21CFR210/211/820/11 and experience with an electronic document management system preferred.
• Detail oriented and well organized
• Strong verbal and written communication skills
• Ability to handle multiple tasks simultaneously
• Adaptable to change in the work environment
• Ability to work in a fast-paced environment
• Ability to work in a team environment, as well as independently
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line