3rd Shift, QA Specialist

* Performs, interprets, reviews, and approves equipment/process validation/qualification activities. Provides review and approval of change control documents.
* Performs and coordinates in-depth system based, process and audits as it relates to compliance concerns and communicates and manages any resulting corrective action plan.
* Performs finished product release activities to include CBER Release requirements. Accepts delegated authority for review and release of materials / documents designated for domestic and international distribution as required.

Note:

Specialists and Senior Specialists with a Science Degree are the only personnel authorized to perform the final release of intermediate (for further processing) and finished goods for domestic,  EU, and international markets. Specialists and Senior Specialists (with a non-Science Degree) with equivalent experience are authorized to perform the final release of intermediate (for further processing) and finished goods for domestic and Canadian markets.
* Responsible for defect resolution and the control of material throughout the plant.  Participated in the completion of significant deviations, field alerts, BPDR’s and investigational activities which span multiple sites, divisions and competencies.  Able to interpret policies, regulations, etc. to determine defect classification and appropriate resolution activities and mentor others on these decisions.
* Completes routine stability and packaging investigations and recommends disposition of affected material.
* Possesses excellent technical writing skills and drives peers and customers to provide robust investigations.
* Challenges technical support and production groups to ensure robust root cause analysis and identification of corrective actions.  Monitors trends and recommends corrective actions to cease continued performance issues.  Able to present data to others outside of working group to gain consensus on appropriate path forward.
* Provides Quality Assurance review and approval of all GMP-related SOPs.
Develops programs / procedures to improve compliance status of Wilson operations.
* Ensures that all SOPs and documentation associated with the Quality systems are maintained and adhered to.
* Supports the environmental monitoring program as needed.
* Performs a variety of regulatory document reviews.
* Manages, tracks and trends a variety of compliance performance indicators, recommends appropriate actions to drive compliance improvement.
* Resolve and escalate issues impacting supply within the daily, weekly, and monthly IPT management processes.
* Performs other duties as assigned.
* Ensure a culture of inclusion and consistency is maintained, supporting positive employee relations within the Quality team and site.
* Actively participate on cross-functional teams in an inclusive manner to advance project goals and achieve deliverables.
* Responsible for knowledge of cGMP and safety requirements.
* Routinely makes decisions to meet performance objectives using cGMP and safety knowledge as a guide.
* Manages activities to identify and correct problems, emphasizing prompt and definitive resolution to minimize adverse impact and reoccurrence.
* Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes.  Reports to the Director for general advice and instruction, but normally handles routine matters independently, consulting on major problems only.
* Applies leadership principles to all actions.
* Maintains 5S organization and identifies improvement opportunities.
* Promotes an environment conducive with the 12 inclusive behaviors, actively promotes an inclusive culture and leads by example.
* Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents.
* Ensure that Rota Teq(R) Quality activities are executed in compliance with Safety, Environmental, cGMP, and Labor regulations.
* Investigate, determine root cause, and implement robust CAPAs for any compliance discrepancies noted during day to day activities and/or audits.  Escalate as per IPT management processes.
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