Sr. QA Associate

Job Summary:

Responsible for independent execution of Quality Assurance activities, and for providing support to manufacturing and validation activities. Provides expertise in Quality guidance to resolve quality issues and ensure GMP operations are in compliance with internal procedures, policies, quality standards, and regulatory requirements.

Responsibilities & Duties:

·         Independently executes QA Operations in change control, document control, deviation resolution, and batch record review.

·         Responsible for management of CAPA system and for reviewing and approving deviation and corrective action reports.

·         Responsible for review and approval of validation protocols and summary reports.

·         Work effectively with Manufacturing, QC and Development personnel to address quality issues.

·         Perform final QA disposition of vaccine lots.

·         Assist in the development and implementation of Quality System and the creation and implementation of quality policies, and procedures.

·         Designs and conduct employee training sessions in Quality Systems.

·         Writes Quality Agreements with external contract manufacturers.

·         Ensure document changes, change requests, record review, DERs, and CAPA’s are performed in compliance with SOPs, cGMP regulations and all applicable US and international regulatory requirements. Provide guidance to members of the QA group as needed.

·         Provides leadership and works closely with technical experts, Manufacturing, QC, and QA in establishing a comprehensive and effective deviation investigation strategy.

·         Actively pursues corporate timelines and milestones set by the department director and upper management.

 

General Responsibilities:

·         Complies with company safety policies and minimizes risk to self, others and the environment, consistent with the community and industry standards.

·         Operates to the highest ethical and moral standards. Complies with policies and procedures for timely completion of company and department goals and objectives.

·         Adheres to quality standards set by regulations, company policy and company mission.

·         Communicates effectively with supervisors, colleagues and subordinates. Is committed to team effort and is willing to assist in unrelated job areas when called upon.

·         Attempts to constructively resolve any problems that interfere with completion of position responsibilities.

·         For any scheduled timeline (or meeting) understands his/her role and meets timelines. Is prepared to provide updates and information pertinent to his/her project(s) at any given time.

Requirements:

·         BA/BS in science or equivalent.

·         6 to 8 years of experience working in the biotech or pharmaceutical industry in a Quality Assurance role, with an emphasis on cGMP quality system management.

·         A sound understanding and working knowledge of current and proposed GXP regulations is essential.

·         Experience in GMP manufacturing required.

·         Excellent communication, writing and decision making skills.

·         Demonstrates good analytical problem solving skills.

·         Well organized, detailed oriented, and ability to handle multiple tasks.

·         Ability to work independently, proactively and in a team environment is essential.