Senior Quality Analyst

Job Responsibilities:

• Conduct microbiological, molecular, and cell culture assays for both in-process and final product samples.
• Assist in transferring methodologies from other groups and may manage complex equipment.
• Maintain a safe, efficient, functional, and compliant cGMP laboratory according to regulatory, site, and corporate guidelines.
• Oversee day-to-day operations that include cGMP routine/non-routine testing of in-process, drug substance, final product, virus banks, and cell banks following respective procedures.
• Support of our clinical and commercial AAV-based products. 
• Author reports, Standard Operating Procedures (SOPs), and other documentation for quality testing and equipment.
• Provide training and technical leadership to less experienced staff members.
• Support method validation and analytical technology transfer activities partnered with QC Technical Services and QA.
• Initiate, review, lead, and/or manage QMS not limited to: Change Controls, Deviations, Out of Specification, Out of Tolerance and CAPA including.
• Participate in or conduct laboratory investigations and address non-conformance deviations.
• Perform finished product reviews and oversee lot releases.
• Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing and testing.
• Strong knowledge of basic analytical techniques in a QC/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)
• Participate in the execution of corrective and preventative action plans, as well as initiate and follow through with change controls.
• Exercise judgment and decision-making skills to solve problems.
• Communicate with other departments and external contacts to resolve technical issues.
• Act as role models for fellow employees and business partners by behaving responsibly, fairly, and honestly, and exercising sound judgment in job performance.

Qualifications:

• Bachelor’s Degree with a minimum of 1-3 years of relevant industry experience in a CGMP lab environment, or equivalent.
• Master’s Degree with a minimum of 2-5 years of relevant industry experience in a CGMP lab environment, or equivalent.
• Proven experience as a technical leader in a strong team environment and the ability to work independently to balance short and long-term project objectives successfully.
• Experience with Deviation Management, Change Control, Data Review, and CAPAs.
• Proficiency with complex analytical methods, such as PCR-based methodologies or cell culture techniques.
• Experience with assay/equipment validations and transfers.
• Cell culture experience (human derived cell lines) is required
• Experience within Bioanalytical/Bioassay/Virology