Overview
Senior Quality Assurance Specialist Jobs in Grove City, Ohio, USA at EPM Scientific
Join a dynamic pharmaceutical manufacturing company as a Senior Quality Assurance Specialist to enhance quality systems and lead validation activities. This organization is dedicated to fostering growth and innovation in the scientific community, partnering with numerous pharmaceutical companies to address some of the most pressing healthcare challenges globally.
Key Responsibilities:
Define and lead comprehensive Quality/CSV projects with autonomy.
Provide mentorship and support to less experienced team members.
Conduct thorough reviews of prior assessments from third parties and coordinate documentation to create a complete Validation Inventory List and Project Plan.
Oversee entire project management from initiation to completion.
Develop and maintain a Gantt chart that outlines project deliverables and resource allocation.
Track and maintain an inventory of project documents and their status.
Create and deliver necessary project artifacts.
Guide team members to ensure high-quality documentation delivery.
Update existing documents and create new ones, aligning with client documentation standards as specified in the Validation Inventory List and timeline.
Key Requirements:
Willingness to travel to a site in Grove City, Ohio, 5 to 7 times based on project requirements.
Proven experience in project leadership.
Strong business acumen and interpersonal skills for effective communication and collaboration.
Proficiency in articulating requirements (both written and oral) clearly to various levels within the client organization.
Ability to mentor and guide junior team members.
Excellent communication skills with clients.
Demonstrated ability to identify expansion opportunities for the business and effectively report them to senior management.
Intermediate skills in Microsoft Project.
In-depth knowledge of Quality system principles, including FDA Quality System Regulations (cGMP), ISO 13485 standards for medical devices, ISO 9001 Quality Management Systems, and ISO 14971 Risk Management Systems.
Please apply if you believe your skills and experience align with this exciting opportunity!
Title: Senior Quality Assurance Specialist
Company: EPM Scientific
Location: Grove City, Ohio, USA
Category: Quality Assurance – QA/QC
