ARGOS IS GROWING!
After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources. Those new resources include a well-qualified Sr. Quality Assurance Validation Specialist.
Provide QA oversight of Validation programs at Argos, including review and approval of IQ/OQ/PQdocumentation. Ensures that all new or existing equipment, utilities, methods, and processes are adequately validated in accordance with company and regulatory requirements.
- Provide QA oversight and/or review during the validation process
- Supports the Validation department in evaluating all tests needed to qualify critical equipment, utilities, methods, and processes
- Performs Quality review and/or approval of Validation Protocols and Final Reports in support of validation efforts
- Performs Quality review and/or approval of all applicable deviations, investigations, and CAPAs related to qualification and validation
- Reviews and oversees execution of FAT, SAT and equipment commissioning activities as required
- Reviews and suggests continuous improvements to Master Validation Plans, quality system practices, validation protocols and procedures and overall validation strategies
- Develops and revises applicable SOPs and provides compliance oversight and support to other departments upon request
- Supports and participates in the change control process for critical equipment, utilities, methods and processes
- Completes appropriate documentation to assure compliance with GMP and Specifications
- Establish work priorities to meet targets and timelines
- Participate in Core Member process teams, as needed
- Other duties as required
- Prefer Bachelors or Masters degree in a scientific, engineering discipline or equivalent
- A minimum of seven years industrial cGMP experience in an FDA regulated Biopharmaceutical
environment with 5+ years QA validation experience
- Solid knowledge of qualification/validation principals and their practical applications
- Previous experience with the start-up and validation of a cGMP facility is preferred
- Strong written and verbal communication skills
- Strong computer skills (Word, Excel, PowerPoint, etc.)
- Strong interpersonal communication skills
- Demonstrated initiative and attention to detail
- Demonstrated ability to multitask and meet deadlines
- Ability and desire to work in cross-functional teams
- Ability to work independently with minimal direction
- 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.