QA Documentation Specialist I

Summary of Primary Responsibilities:

The Quality Assurance Documentation Specialist I 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, performs records maintenance and training program 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.

Specific Responsibilities:

• Responsible for collection, maintenance, distribution, archiving and filing documents necessary to ensure compliance with the quality management system and regulatory requirements.

• Maintain appropriate filing structure to keep archived material identified, secure, and easily retrievable when needed. Maintain archive database for accuracy of documentation details and location.
• Prepare and coordinate documentation transfer of Quality documents and records to on-site and offsite archive.
• Issue manufacturing and packaging batch records to meet production schedule requirements.
• Review records for accuracy and good documentation practices. Provide personnel support with documentation and record needs.
• Responsible for executing the workflow of the document control department and for training others on document related procedures and processes.

• With minimal supervision, conduct and champion documentation control programs. Coordinate document workflows. Perform controlled document lifecycle processes according to established procedures.
• Manage user creation accounts and training assignments accordance to on/off boarding.
• Maintain training records in accordance with SOP and current practices. Collaborate with document authors to define appropriate training method.
• Monitor and maintain shared email groups and provide assistance with internal customer requests.
• Support internal/external audits as needed.
• Perform other related duties and projects as assigned.

Job Complexity:

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. Position has a customer service orientation and a high degree of attention to detail.

Supervisor Responsibilities:

No direct reports.

Experience, Knowledge and Skills Required:

• Position requires a high school diploma; Associate degree in life sciences, business or other related field or related experience.
• Minimum 2-5 years of experience in a cGMP regulated environment (pharmaceutical or medical device industry) with at least 1 year in Quality Systems document control administration is required.
• Experience with MasterControl or other Quality Management System software is highly desirable.
• Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, auditors, contractors and consultants.
• Understanding of FDA Quality System Regulations, ISO 13485, cGMP, MDD & EU MDR standards.
• Ability to work autonomously, effectively manage time and deliver results on time.
• Excellent verbal and written communication skills.
• Strong organization skills with high attention to detail.
• Must be proficient in MS Office.

Physical Ability Requirements:

• Ability to lift and carry, and move boxes or file weighing up to 25 to 30 pounds (or as needed) in order to organize or store documents.