Anika · 20 hours ago
QA Documentation Specialist I
Bedford, MA, US
Full-time
Onsite
Entry, Mid Level
$65K/yr - $80K/yr
2+ years expAnika is a company focused on quality assurance in the pharmaceutical and medical device industry, and they are seeking a QA Documentation Specialist I. This role is responsible for maintaining documentation and record-keeping processes to ensure compliance with the Quality Management System.
BiotechnologyHealth CareManufacturingTherapeutics
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
Qualification
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
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
Preferred
Experience with MasterControl or other Quality Management System software is highly desirable
Benefits
Discretionary bonus program for all full-time employees
Comprehensive healthcare benefits
Health savings account
401(k) plan with up to 5% company match which includes immediate vesting
Employee stock purchase plan at a 15% discount
Accrued paid time off
Additional long-term incentives including stock awards
Robust Total Rewards, inclusive of market-leading benefits
Company
Anika
Anika is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care.
201-500 employees
H1B Sponsorship
Anika has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (1)
2022 (1)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
Caligan Partners
2024-03-07Post Ipo Equity
1993-05-14IPO
Leadership Team
Cheryl Blanchard
President and CEO
Recent News
GlobeNewswire
2026-01-09
2026-01-09
Company data provided by crunchbase