The Role

Reporting to the Manager, Quality Assurance (QA) the Senior Associate, Quality Assurance will be primarily responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with Manufacturing, Engineering, Validation, Supply Chain, Facilities, Document/Data Management, and other GxP supporting functions to ensure compliance. This is accomplished by direct collaboration and oversight of Validation, Facilities/Engineering, Manufacturing Operations, and the review/audit of data and reports as specified by Standard Operating Procedures. This position will be based in our Sanford, NC facility.

Primary Responsibilities

• Perform review and approval of master production batch records.

• Author, review, and approve Quality System records including Deviation, CAPA, and Change records including associated causal and impact assessments.

• Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOP’s, material specifications, validation protocols, and reports.

• Develop and execute QA Area Walkthrough process.

• Review and approval of Work Orders.

• Review of functional area logbooks (equipment, cleaning, etc.)

• Inspect and release GMP raw materials and components against approved specifications.

• Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements.

• Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections, as necessary.

• Proactively identify gaps or system enhancements and shepherd to completion, as required.

Must Have/Required

• Must Have/Required

• Senior Associate, Quality Assurance : Bachelor’s degree in a related scientific or technical discipline with 6+ years of hands-on experience in a QA function in a biologics manufacturing facility or Master’s degree with 4+ years of hands-on experience in a QA function in a biologics manufacturing facility or equivalent experience.

• Knowledge of U.S. and international regulatory standards and guidelines

• Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects

• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others

• Excellent problem-solving skills and experience with root cause investigations and CAPA determination

• Strong computer skills including MS Office (Word, Excel)

• Off hours coverage and flexibility may be required

• Physical Requirements: Able to frequently lift, carry or move, and position objects weighing up to 30 pounds. Able to bend, stoop and crouch to inspect materials or place labels. Consistently able to move about to coordinate work

• Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted May Have/Preferred

• Experience with rare diseases, neuromuscular diseases and/or gene therapy products

• Experience in a small company and high growth, fast-paced environment

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, national holidays, two Heritage Days, and Summer and Winter Breaks

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Referral bonus program

Category Product QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans