Document Control, Senior Specialist
$111,000–$111,000 year
On-siteBedford, Massachusetts, United States
Job Summary
Senior Specialist, Document Control at Lantheus in Bedford, MA, oversees and administers the corporate document control program within the Quality Systems and Compliance team. Responsibilities include managing the lifecycle of controlled quality documents in the electronic document management system (eDMS TrackWise Digital), ensuring documents are established, reviewed, approved, issued, revised, archived, and obsoleted in a compliant manner, supporting inspection readiness, and driving process improvements. The role partners with corporate and site functions to maintain document governance, provide SME guidance, support eDMS migrations, coordinate document development workflows, ensure proper formatting and versioning, facilitate audits and regulatory inspections, and train related stakeholders. On-site requirement: three days per week in Bedford, MA, with eligibility to work for any employer within the United States.
Required Qualifications
- BS/BA degree with minimum of 8-10 years of experience in a quality discipline, with a minimum of 5 years within Document Control in the pharmaceutical, medical device, or biological industries.
- Experience with electronic Quality Management Systems (eQMS) or document management platforms such as TrackWise Digital, Veeva, MasterControl, or similar systems.
- Experience with global or multi-site document control programs.
- Experience supporting harmonization or transformation of document control processes in a growing or complex organization.
- Demonstrated experience administering GxP controlled documentation within an eDMS.
- Strong knowledge of document control principles, quality systems, and controlled documentation practices in regulated environments.
- Knowledge of retention and archival requirements for GxP records.
- Experienced with supporting pharmaceutical and/or medical device GMP compliance regulatory inspections.
- Proficient in technical writing skills.
- Expertise in MS office suite programs.
Desired Qualifications
- Good planning and project management skills.
- Good verbal, written and presentation skills at all levels both internally and externally.
- Ability to communicate effectively at a variety of levels of the organization, as well as coach and mentor members of GxP functions on compliance requirements and topics.
- Must be detail oriented with the ability to multitask and respond to ever changing priorities.
- Strong attention to detail with the ability to ensure accuracy, completeness, and consistency of controlled documentation.
- Ability to work independently and drive on time completion of responsibilities and assigned tasks.
- Core Values
- Let people be their best
- Respect one another and act as one
- Learn, adapt, and win
- Know someone’s health is in our hands
- Own the solution and make it happen
- The pay range for this position is between $111,000 and $185,000 annually.
- Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equ…
- Lantheus is committed to
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.