Contract, Quality Assurance Associate

We are seeking a highly motivated Contract, Quality Assurance Associate to be responsible for ensuring compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and company practices. This role is accountable for routine Quality Assurance duties related to the production and disposition of products manufactured and tested on behalf of Neogene. This role is based in Santa Monica, CA, and reports to Director of Quality in Santa Monica, CA.

Responsibilities

• Provide QA guidance on product development projects and technical transfer activities
• Develop QA Standard Operating Procedures to ensure Quality objectives are met
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Provide quality assurance support across functions (Manufacturing, Supply Chain, QC, Process Development, Regulatory Affairs) within Neogene and externally to assure compliance and strong relationships.
• Support regulatory inspections, internal audits, and external audits from partners.
• Develops solutions to more complex problems.
• Reviews routine manufacturing and quality control data for in-process and finished product.
• Review and approval of Deviations and CAPAs Support Disposition of product for U.S. and other countries.
• Batch documentation review and ensure resolution of issues to release product.
• Support of New Product Introductions.
• Perform other duties as assigned.
• Support quality assessments of internal operations to analyze quality compliance and assess risk.
• Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Support Management Review activities and oversee trending of key quality, product and GMP metrics.

Requirements

• Experience writing, evaluating and closing investigations, CAPAs and change control records.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Proficient in MS Word, Excel, Power Point and other applications.
• Ability to effectively negotiate and build collaboration amongst individuals.
• Proficient in cGMP regulations, quality systems and regulatory requirements.
• Willingness to think outside of the box and adapt best practices for stage appropriate products.
• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Experience with conducting and managing internal and external audits.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.
• Bachelor's Degree and 3 + years of experience in a GMP environment.

**You must be incorporated or willing to be OR you must be represented by an agency to apply for this contract role. An agency can be provided if you do not have representation**

At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.