Document Control and Records Specialist
Location: Bedford, MA
Summary of Primary Responsibilities:
The Document Control Coordinator is a quality focused individual who ensures documentation and record keeping processes conform to approved procedures and output documents are accurate. This role will support the organization by maintaining documents required by the Quality Management System (QMS). Working closely with the Anika Document Management and Training team, this position assist in Batch Record Issuance and perform records maintenance within our validated eQMS system. This role will also assist with other Anika team members and oversee off-site storage and scanning of records and documents.
- Responsible for collection, maintenance, distribution, archiving and filing documents necessary to ensure compliance with the quality management system and regulatory requirements.
- Review records for accuracy and good documentation practices. Provide personnel support with documentation and record needs.
- Understanding of document change control and record management.
- Strong organization skills with high attention to detail.
- Assist with records management practices within Master Control, as necessary
- Assist in performing Batch Record Issuance in support of Manufacturing operations.
- Demonstrated experience successfully working with teams across many cultures and/or worksites.
- Support internal/external audits as needed.
- Performs other general administrative duties as assigned.
Requires accuracy, strong organizational skills, and the ability to multi-task. Exercises judgment within generally defined practices and policies in selecting method and techniques for obtaining solutions.
No direct reports.
Experience, Knowledge and Skills Required:
- Position requires a high school diploma; Associate degree is preferred
- Minimum of 2 years of experience in Quality Systems document control administration is required
- Detail oriented and exceptionally attentive to accuracy.
- Able to identify GDP errors
- Ability to manage multiple tasks and to learn skills quickly
- Must be proficient in MS Office
- Experience with MasterControl or other Quality Management System software is highly desirable
- Working knowledge of FDA, QSR, GMP, and ISO13485 is a plus
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.