Sr. Quality Assurance Specialist

This role is based at our office in Vista, CA.

The primary responsibility of the Sr. Quality Assurance (QA) Specialist is to work with several Quality Systems ensuring compliance is maintained to meet the current regulatory requirements. The Quality Systems are Deviation Management, Non-Conforming Materials, CAPA, and Customer Complaints. The Sr. QA Specialist is responsible for product quality by evaluating various processes against validated methods and licensed parameters, while ensuring timely product release.

Will interface with multiple departments to ensure successful results. The position will support regulatory reporting and communications as required. Other responsibilities will include individual and group projects to support Quality Assurance initiatives across the company.

ESSENTIAL DUTIES & RESPONSIBILITIES (other duties may be assigned)

• Investigate and report as required, issues identified under the deviation management system including database management.
• Focus on thorough investigations, sound root causes, meaningful corrective actions and identify areas where deviation reoccurrence could be avoided.
• Work with various departments in the development of effective corrective and preventative actions. Follow up effectiveness evaluation and database management.
• Investigate and report on customer complaints and administer the customer complaint database. Interface with various departments to investigate and ensure timely resolution of complaints. Report both to the investigation file and to the customer.
• Responsible for maintaining the Quality Risk Management system and providing support to other departments as needed.
• Responsible for timely completion of the annual product review and other periodic reports as required.
• Coordinate and manage investigations relating to trend analysis or problem areas requiring investigation utilizing multiple resources.
• Assist in the closure of Out of Tolerance events, processing of Facilities Change Requests and the review of Documentation Change Requests.
• Perform housekeeping inspections of manufacturing areas, report issues to area management, and ensure closure of all inspection findings.
• Support regulatory submissions and responses as required.
• Provide scientific and/or technical advice and counsel regarding projects as needed.
• Participate in departmental and cross functional team meetings and/or assemble cross functional teams and/or facilitate team meetings as necessary.
• Maintain current knowledge of regulatory and industry standards.
• Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
• Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
• Strict adherence to procedures and practices according to FDA regulations.
• Adhere to departmental corporate safety policies.
• Assist management in coordinating and scheduling the department's day-to-day operations.
• Serves in a leadership role in the absence of direct supervision.

EDUCATION & EXPERIENCE

• Bachelor’s degree in Biology, Chemistry, Microbiology, Biochemistry or closely related scientific / technical discipline is required.
• Minimum of 5 years of experience in a pharmaceutical, GMP, or FDA regulated environment is required. Direct experience in Quality Assurance, Quality Operations, Quality Control or Quality Engineering function is required.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example:
If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

KNOWLEDGE | SKILLS | ABILITIES

• Requires an in depth understanding of pharmaceutical manufacturing, aseptic processing, laboratory processes and Quality Assurance / Operations. Knowledge or background in Quality systems and theory is required.
• Comprehensive knowledge and…