QA Associate I
Azzur Lab is looking for a highly motivated QA Associate I to manage a GMP/GLP laboratory's Quality Assurance program. This is an exciting new position in a well-established life sciences company, where you will be assisting in the expansion of new lab functions and capabilities, as well as supporting to grow an entrepreneurial, scientifically-driven organization that is passionate about helping clients on their life-saving drug development. Reporting to the Sr. Director, the successful applicant will be operationally-minded and comfortable supporting several dynamic and diverse groups within the Azzur Labs department, as well as clients and external vendors.
Duties and Responsibilities
- Assist QC in establishing quality oversight for testing, data integrity, test results deployment, quality documentation, and clinical/commercial test launch for lab services QA disposition.
- Implement efficient and compliant processes for protocol, SOP, report, and change control management preparation, execution, review, approval, and archiving.
- Manage the laboratory's quality assurance program, which includes activities such as specimen collection, handling, reporting, quality control, quality and GLP controlled documentation review/approval, proficiency testing, drug test release, and sample disposition.
- Ensure appropriate metrics and tracking are in place for operational monitoring and as early key indicators for operational issues.
- Conduct timely root cause analysis, lab investigations, and reports for deviations, out-of-specifications, out-of-trend observations, corrective and preventive action (CAPA) plans, and change controls in accordance with quality/regulatory compliance.
- Appropriate CAPAs must be implemented on time to avoid recurrences.
- Track and trend deviations, corrective actions, and QC data in collaboration with functional SMEs and external stakeholders.
- Assist in verifying that the testing steps, data, and testing results are accurate and in accordance with company policies, GMP, GDP, and data integrity.
- Support/lead risk management activities, including risk mitigation plans and implementation.
- Work closely with cross-functional partners to prepare for and support agency inspections, sponsor audits, and site visits. Assist in responding to information requests, adjudicate compliance discussions, and mitigate any necessary corrective actions resulting from these activities.
- Coordinate and execute quality assurance activities during technology transfer projects.
- Help to create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence.
- Proactively identify, escalate, and implement tools and processes to enhance operational and planning efficiencies.
- Establish quality measures and identify ways to improve efficiency and cost.
- Support supplier quality management activities, including audits, and quality agreement reviews.
- Collaborate closely and timely with internal and external stakeholders to support the associated lab functions of the entire assignment or project.
Qualifications and preferred experience:
- Possesses a bachelor’s degree in life sciences or higher.
- 3+ years of relevant scientific/technical/business and industry experience, preferably in a CRO setting.
- Knowledge and experience in quality assurance operation role.
- In-depth knowledge of GxP and ICH compliance relevant to a GMP QC lab operation.
- Well-developed written and oral communication skills. Motivated to work in a team environment.
- Excellent attention to detail with accuracy and proficiency on QA operation.
- Operational excellence experience, such as LEAN, DMAIC, and Six Sigma is desirable.
- Good troubleshooting and conflict resolution skills.
- A self-starter and a great communicator with a keen sense of execution and collaboration.
- Critical thinking and problem solving skills.
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
- Willing to work hands on with multiple clients
- Ensures activities are efficient, optimized, and client centric.
- Highly motivated and organized, solutions-oriented leader
- Curious and adaptable - has the ability to transform knowledge into actionable activities
- Able to produce results in a fast paced, collaborative environment
- Medical, Dental and Vision
- Competitive 401K plan
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.
No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business.
We are seeking highly motivated individuals that have the desire to learn, are able to adapt to the ever-changing life sciences field and are flexible to work on various projects all while exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
We aim to serve our clients, create a healthy and fun work environment, and assist with professional growth for everyone through customized career development plans.
If a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you!