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 Senior Quality Assurance Auditor.
This position will plan and conduct quality audits. The person in this role is responsible for scheduling and conducting supplier and internal audits as well as overseeing corrective actions. This person will be required to travel to supplier locations.
- Perform routine, initial, and follow up audits including internal quality systems audit and external audits to support the Argos Supplier Quality program.
- Provide compliance guidance and support throughout the Quality and Compliance organization, and participate in multi-departmental teams and initiatives.
- Independently schedule, conduct and report on internal and external foreign and domestic audit activities of a complex nature.
- Plan and strategize long term audit programs and department activities, such as internal facility training, internal site visits, and participate on various companywide teams and projects.
- Review and audit Internal and external quality systems.
- Provide quality guidance and support to Operations functions by assessing, troubleshooting and recommending solutions to resolve compliance issues.
- Contribute to various companywide harmonization efforts, e.g. supplier management, audit tracking modules, and training modules /programs.
- Stay current with Regulatory and Industry compliance trends and adopt auditing strategies as appropriate.
- Participate in intercompany working groups.
- BS/MS degree in a scientific or engineering discipline or equivalent.
- Minimum of 7 yearsâ€™ experience in the biopharmaceutical industry, 5 of those years in Quality Assurance, and a minimum of 2 years as QA Auditor. GCP experience is a plus.
- Knowledge of pharmaceutical quality industry regulations FDA, GMP, GLP, ICH, 21 CFR 210 and 211, 21 CFR Part 11, and International Standards, ICH 8, 9, 10, USP/EP/JP Compendia, and ISO 9001.
- Must have strong collaborative skills and work well as part of a team.
- Excellent problem solving skills, and experience resolving/explaining complex deviations/production discrepancies.
- 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.
- Strong interpersonal, oral and written communication skills with the ability to create a high level of teamwork and team/individual accomplishment.
- Detail oriented with proven organization skills.
- Ability and willingness to be regularly, predictable and reliably at work.
- Ability to travel at least 50-75% of the time.
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.