Quality Assurance Manager Argos Therapeutics
THIS JOB HAS EXPIRED After having met several important milestones, including exciting clinical data, Argos Therapeutics is poised for new strategic objectives which will require significant new resources. Those new resources include a Quality Assurance Manager.
SCOPE: Under the direction of the Quality Assurance Director, oversees the development, implementation, and maintenance of quality assurance systems and activities.
Provide management of QA staff employees
Review and approve cGMP documentation including Item Specifications, SOPs, Master Production Records, Standard test Methods, validation protocols and reports
Review and approve completed batch records, test results, investigations and change control.
Release final product for clinical use to meet project goals.
Oversee review and approve executed Batch Production Records, executed stability and validation protocols/reports
Manage Deviation, CAPA, Change Control and non-conforming materials systems
Develop and perform cGMP and Quality Systems training
Act as an advisor to QA and other departments regarding quality and compliance issues
Work on problems of moderate scope in which analysis of the situation or data requires a review of identifiable factors, such as those exhibited in Deviation Reports
May assist in product shipments, and review and release of incoming raw materials
Chair Material Review Board meetings
Perform internal and external audits
Perform raw material and final product release
Other duties as required
Prefer BS/Masters degree in a scientific or engineering discipline or equivalent
Minimum of 8+ years of related experience with a BS degree or 5 to 8 years of experience with a Masters degree with working knowledge of scientific principles and cGMPs
Demonstrated ability to provide leadership and supervision to staff members
Must have experience auditing to cGMP standards and writing and maintaining controlled documents
Ability to analyze data and to assess and assist in resolution of extremely complex problems
Strong writing and verbal communication skills
Strong computer skills (Word, Excel, PowerPoint, etc.)
Strong, professional interpersonal skills
Demonstrated initiative and attention to detail
Demonstrated ability to multitask and meet deadlines
Ability to contribute to cross-functional teams while providing independent judgment regarding compliance issues
Ability and willingness to be regularly, predictable and reliably at work
Willingness to travel up to 20% of the time
Ability and willingness to be regularly, predictably and reliably at work.
We offer a competitive compensation package along with outstanding benefits. For confidential consideration, please submit a resume with a cover letter and salary history.
No phone calls please.
Argos Therapeutics is an Equal Opportunity Employer.
||4233 Technology Drive |
Durham, NC 27704
THIS JOB HAS EXPIRED