Apply on Employer Site

Merck · 1 day ago

Manager, Quality Assurance

Millsboro, DE

Full-time

Hybrid

Mid, Senior Level

$96K/yr - $151K/yr

5+ years exp

Merck is a global leader in healthcare, committed to delivering high-quality products. The Quality Assurance Manager will direct QA activities at the Millsboro site, ensuring compliance with regulatory standards and managing a team to uphold quality processes.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Prioritizing the schedule of Quality activities in accordance with customer requirements

Performing Quality review, approval, and submission of finished product serials

Managing Product Release submission process to USDA CVB

Document Management including Batch Record Review and archiving, SOP Management and review, Test Record review and approval, and Regulatory Communications

Performing GMP walk through inspections of assigned departments to ensure compliance with cGMPs and regulatory requirements. Assistance with external audits may also be required

Direct support and management of Regulatory Authority Inspections

Authoring, reviewing and approving revisions to SOPs, technical documents, including risk assessments and investigation reports

Aiding all areas of the site in drafting and review of significant investigations as needed

Performing Quality reviews and approval of new and updated Procedures and Controlled Job Aids

Quality Risk Management oversight

Assisting with annual review of the Site Master Plan

Other duties as required by management

Actively participates in the Tier process and uses this forum to escalate concerns and best practices

Qualification

Quality Assurance (QA)GMP ComplianceAseptic ProcessingAnalytical TestingDeviation InvestigationsDocument ManagementQuality Management Systems (QMS)Cross-Functional TeamworkDetail-OrientedProblem-Solving Skills

Required

Associate's degree in a scientific or analytical field, with (8) years' relevant experience. Candidates with degrees in other fields will be considered if accompanied by significant relevant experience

Bachelor's degree in scientific or analytical field, with five (5) years' relevant experience

Master's degree in scientific or analytical field, with three (3) years relevant experience

Minimum of Five (5) years of experience in Biological operations, technical services and/or Quality operations with experience understanding the quality function

A minimum of one (1) year of experience in a leadership role (manager, supervisor or lead position)

Knowledge of aseptic processing and sterility assurance

Proven problem-solving skills

Analytical Testing

Aseptic Processing

Biomanufacturing

Change Management

Configuration Management (CM)

Cross-Functional Teamwork

Detail-Oriented

Deviation Investigations

Document Management