Overview
We are seeking a Document Control/QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 a.m. EST - 4:30 p.m. EST.
The Document Control/QA Associate I will report directly to the QA/QC Director.
This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting the document control department in processing documentation requests. They will work closely with cross-functional teams and within document control and overall quality department to ensure the changes are accurate and are made effective in a timely manner while also serving as a resource for the review of quality documentation received from interdepartmental sources.
Responsibilities
- Works with subject matter experts, area managers and senior level Document Control and QA-personnel to properly convert documentation into the final written form and ensure the appropriate document approvals are obtained prior to documentation becoming effective.
- Prepares and publishes approved documentation in a timely manner to meet established deadlines (paper and electronic).
- Maintains related database systems, if applicable, logs and complete forms/records as required.
- Adheres to written policies and procedures related to performing assigned tasks.
- Collaborating with the team to resolve issues, maintains time lines and plans to meet the company’s needs in the area of document control and overall quality department.
- Organize and update training files as necessary to maintain compliance.
- Copy, scan, and file records appropriately.
- Process requests and generates labels and batch records for production.
- Documentation Archival, on and off-site.
- Assist and supports On-Boarding Training.
- Assists with employee Overdue Training
- Tasks associated with the review of production and quality-specific documentation as assigned for purposes of the release of production assemblies.
Qualifications
- Bachelor’s degree in Biological Science or other science related discipline
- Minimum 1-2 years’ experience in Document Control in an ISO 9001 certified Quality Management System or equivalent
- Strong knowledge of Microsoft Office, including Word and Excel. MS Access a plus. Ability to communicate with multiple departments and associates
- Shares timely information with peers, Lead and/or Management on daily progress
- Ability to contribute to project teams
- Focus and attention to detail is critical
- Working knowledge of documentation functions within a cGMP or ISO regulated environment is preferred
- Strong verbal, written and interpersonal communication skills
- Detail-oriented with the ability to multitask in a fast-paced environment
- Knowledge of SAP is helpful
- Understanding of Good Documentation Practices preferred.
What Repligen Offers
Repligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, generous PTO, partial compensation on your personal health insurance and flexible working hours. But most importantly Repligen offers you a stimulating, collaborative environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Waltham, MA.
