QA Documentation Specialist I
Anika
1 month ago
Remote friendly (Bedford, MA)
United States
$65,000 - $80,000 USD yearly
Operations
Responsibilities:
- Ensure documentation and record keeping processes conform to approved procedures and output documents are accurate.
- Collect, maintain, distribute, archive, and file quality management system documents and records to meet compliance and regulatory requirements.
- Maintain secure, easily retrievable filing structures and an archive database (accuracy of documentation details and locations).
- Prepare and coordinate transfer of quality documents and records to on-site and offsite archives.
- Issue manufacturing and packaging batch records to meet production schedules.
- Review records for accuracy and good documentation practices; support personnel with documentation and record needs.
- Execute document control department workflows; train others on document-related procedures and processes.
- Champion documentation control programs; coordinate document workflows; perform controlled document lifecycle activities.
- Manage user creation accounts and training assignments in accordance with onboarding/off-boarding.
- Maintain training records per SOP; collaborate with document authors on appropriate training methods.
- Monitor and maintain shared email groups; assist internal customers.
- Support internal and external audits as needed.
- Perform other related duties and projects as assigned.
Qualifications / Required:
- High school diploma; associate degree in life sciences, business, or related field, or related experience.
- 2–5 years of experience in a cGMP regulated environment (pharmaceutical or medical device), including at least 1 year in Quality Systems document control administration.
Skills / Preferred:
- Experience with MasterControl or other Quality Management System software (highly desirable).
- Understanding of FDA Quality System Regulations, ISO 13485, cGMP, MDD, and EU MDR standards.
- Strong organizational skills and attention to detail; ability to multitask and work autonomously.
- Excellent verbal and written communication skills.
- Proficient in MS Office.
Physical Ability:
- Ability to lift/carry/move boxes or files up to 25–30 pounds to organize or store documents.
Benefits (if applicable):
- Discretionary bonus; comprehensive healthcare benefits; health savings account; 401(k) with up to 5% company match; employee stock purchase plan (15% discount); accrued paid time off; long-term incentives including stock awards.
Application Instructions:
- Not provided in the text.
- Ensure documentation and record keeping processes conform to approved procedures and output documents are accurate.
- Collect, maintain, distribute, archive, and file quality management system documents and records to meet compliance and regulatory requirements.
- Maintain secure, easily retrievable filing structures and an archive database (accuracy of documentation details and locations).
- Prepare and coordinate transfer of quality documents and records to on-site and offsite archives.
- Issue manufacturing and packaging batch records to meet production schedules.
- Review records for accuracy and good documentation practices; support personnel with documentation and record needs.
- Execute document control department workflows; train others on document-related procedures and processes.
- Champion documentation control programs; coordinate document workflows; perform controlled document lifecycle activities.
- Manage user creation accounts and training assignments in accordance with onboarding/off-boarding.
- Maintain training records per SOP; collaborate with document authors on appropriate training methods.
- Monitor and maintain shared email groups; assist internal customers.
- Support internal and external audits as needed.
- Perform other related duties and projects as assigned.
Qualifications / Required:
- High school diploma; associate degree in life sciences, business, or related field, or related experience.
- 2–5 years of experience in a cGMP regulated environment (pharmaceutical or medical device), including at least 1 year in Quality Systems document control administration.
Skills / Preferred:
- Experience with MasterControl or other Quality Management System software (highly desirable).
- Understanding of FDA Quality System Regulations, ISO 13485, cGMP, MDD, and EU MDR standards.
- Strong organizational skills and attention to detail; ability to multitask and work autonomously.
- Excellent verbal and written communication skills.
- Proficient in MS Office.
Physical Ability:
- Ability to lift/carry/move boxes or files up to 25–30 pounds to organize or store documents.
Benefits (if applicable):
- Discretionary bonus; comprehensive healthcare benefits; health savings account; 401(k) with up to 5% company match; employee stock purchase plan (15% discount); accrued paid time off; long-term incentives including stock awards.
Application Instructions:
- Not provided in the text.