Release Manager, QA Disposition

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The Release Manager, QA Disposition Daily Operations is responsible for performing final release and disposition of drug product and issuance of all disposition certification i.e. Certificate of Analysis (CoA), Dose, RFI (release for infusion) certificate at the Summit West facility.

Shift Available:

• Sunday - Wednesday, Onsite Day Shift, 12 p.m. - 10:30 p.m.

Responsibilities:

• Meticulous attention to detail to ensure right first time and compliant release and certificate issuance.

• Current on industry standards as it applies to cGMPs, global regulatory guideline requirements, and departmental requirements.

• Executes Disposition activities in alignment with all pertinent SOPs. Ensures pertinent SOPs are available and present when executing disposition tasks.

• Ensures product quality and compliance by enforcing quality assurance policies and procedures; ensures the required processes, procedures, and resources are adhered to while performing responsibilities.

• Knowledge of US and global cGMP requirements.

• Advanced knowledge and experience with cGMP manufacturing, quality, and compliance to make appropriate decisions as needed.

• Obtains all required accesses needed to perform tasks with minimal delay.

• Action-oriented and customer-focused, skilled in decision-making, building relationships, problem solving, conflict management, and critical thinking.

• Work is self-directed and requires little to no direction to complete tasks by following work practices, lists, forms, and/or procedures.

• Skilled in organizing daily tasks, decision-making, and building relationships.

• Able to adapt as required to support departmental and site wide initiatives.

• Capable of independently troubleshooting complex situations utilizing all available sources of guidance.

• Excellent verbal and written skills to prepare clear and concise communications including communication to senior management.

• Supports and/ or leads continuous improvement initiatives to drive efficiency and productivity within the group and/or site.

• Responsive in forms of communications.

• Relays disposition status in a timely manner in all required platforms.

• Leads projects as required by senior management.

• Compiles metrics for presentation to senior management as required.

• Writes, reviews and updates SOPs as required.

• Recognized as Subject Matter Expert within the group