Quality Supervisor

Merck•Rockville, MD

7d•Onsite

About The Position

As the Quality Supervisor – Document Controls & Archives in Rockville, you will be a working supervisor with primary functional and administrative responsibility for a team who performs a range of tasks. This encompasses report scanning and archival of regulated GxP (e.g., GLP, GMP) studies and management of the Document Control process including management of templates and issuing controlled documents.

Requirements

Bachelor’s Degree in any discipline.
4+ years of experience in Quality Assurance or related field within a GxP environment.
1+ years supervisory or team lead experience.
Acts ethically and ensures quality of own work and that of the QA team.
Collaborates with various teams to identify and implement improvements.
Applies technology to drive digitalization, improve quality and increase customer value.
Works with agility and strong verbal and written communication.
Expert knowledge and application of FDA and EU regulations (cGMP, GLP, Archiving).
Excellent communication, facilitation, and conflict resolution skills.

Nice To Haves

Experience with archives or document control in a quality environment
Bachelor’s degree in a Science or Technical field.

Responsibilities

Supervise staff and organize employees’ schedules.
Assign and monitor work distribution and performance across the team using appropriate tools.
Provide and/or ensure appropriate training, coaching and professional development for personnel.
Provide feedback, complete performance reviews, document performance problems and take appropriate action.
Monitor expenses and resources within department budget.
Provide support for regulatory inspections.
Participate on local quality improvement project teams.