Job Posting for Quality Assurance Supervisor at Celldex Therapeutics
Overview
Join a high performing team of QA staff to help manage and oversee the Quality Assurance functions focused on GLP audits and compliance of Preclinical and Bioanalytical groups, internal GLP/GCP testing, and overall GXP Quality System support. Conduct internal and external audits, manage QA GLP operation, review data and documentation and provide supervision to QA Specialists.
Responsibilities
Manage QA GLP operations
Conduct Bioanalytical data transfer audits
Oversee execution of quality systems to support GLP testing,
Administer, review, follow-up and approve QS documentation
Write, review and approve SOPs
Trend and report QA GLP quality system related information
Perform data review and approval of method and equipment validation
Assist in external audits (Vendors, Suppliers, Sub-Contractors Testing Facilities, Clinical)
Prepare routine updates and project status report of GLP QA activities
Provide QA assistance for GLP supporting GLP testing, ,
GLP SOP, protocol and report review and approval
Perform Internal and external audits
Supervise QA Specialists
Qualifications
Strong knowledge of GLP quality systems, policies and regulations.
Strong supervisory skills
Previous GXP audit experience.
Strong knowledge of DMS, MS Word and Excel.
Excellent written and verbal communication skills.
Must be able to work both independently and in team situations.
Education/Experience:
BA/BS in Life Sciences.
Minimum of 4-6 years GLP experience and GCP experience a plus.
Minimum of 2 years supervisory experience
Excellent interpersonal skills and ability to communicate clearly, effectively, and professionally.
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
Hourly Wage Estimation for Quality Assurance Supervisor in River, MA
$48.19 to $61.34
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