Quality Assurance Associate
Bend, OR
Do you:
- Like finding new and better ways to do things?
- Want to help develop medicines to make patients’ lives better?
- Desire to learn and grow?
- Nerd out on science & technology?
- Value people and working in a collaborative team?
- Desire to be audacious and entrepreneurial?
- Value safety and leading by example?
- Care about doing the right thing?
At Bend Bioscience, we are looking for colleagues with: SCIENTIFIC CURIOSITY, HONESTY, HUMOR, CONFIDENCE, HUMILITY, TRUSTWORTHINESS, RESPECT FOR CO-WORKERS, and the DESIRE TO MAKE A DIFFERENCE AND HELP PATIENTS.
Job Description:
Bend Bioscience is focused on research, development, and clinical production of non-sterile drug delivery technologies, drug products, and intermediates for the pharmaceutical industry. In this role, you will be performing and participating in activities and initiatives related to the support and maintenance our operational Quality Management System. The Quality Assurance Associate is expected to monitor and report on the existing quality systems utilized as well as identify and implement continuous quality process improvements to support our continued growth in the industry.
The Quality Assurance Associate will assist the QA Director in correspondence with internal and external customers, design, and administration of the Quality Management Systems by:
- Ensuring compliance and record-keeping for all mandated quality checks, testing, and inspections.
- Assist in the administration and upkeep of QA programs: Traceability and Recall, Calibration, Document Control, Internal Audits, Supplier Approval, Nonconformance Reports/CAPA, and Customer Complaints.
- Coordinate with outside labs for microbiological and environmental monitoring, verify all lab results to ensure they are within established parameters.
- Be available for customer and third-party audits and act as back-up in the QA Director or QC Managers absence.
- Engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate.
- Ensures appropriate and timely escalation of quality issues, including issues of significant deviations to QA Management and makes appropriate recommendations for correction and improvement.
- Participate/lead risk management activities including FMEAs.
- Draft policies, SOPs, and Work Instructions as needed.
- Perform other related duties as assigned by the Quality Assurance Director.
Characteristics:
- Collaborative
- Commitment to GMP compliance and safety
- Strong interpersonal skills
- Proven ability to work independently, efficiently, and plan successfully
- Strong analytical skills and attention to detail
- Excellent oral and written communication
- Accountable and responsible
Experience and Educational Requirements:
- BS Microbiology, Chemistry, or related field with 3+ years of industry experience in a QA or QC pharmaceutical, biotechnology, or other FDA regulated business.
- Some laboratory experience is desirable, preferably in Quality Control testing and release with familiarity reviewing stability studies.
- Experience and understanding of working in a CDMO GMP environment with ability to use phase appropriate decision making for regulatory compliance.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Experience leading and/or conducting QA audits.
- Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects.
- Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors.
- Experience utilizing root cause analysis tools
- Experience writing and reviewing SOPs.
- Proficiency with Microsoft Office.
- Working knowledge of cGMP (21 CFR 210, 211) quality systems, policies, and regulations/guidelines.