Coding Compliance Specialist jobs in York, PA

As a Supply Chain Compliance Specialist, you will will ensure quality system compliance for the Supply chain department by managing quality system workload, including leading investigations, initiating deviations and determining corrective action, change controls, technical documents, calibration and validation records and documentation, SOPs (standard operating procedures), regulatory policies, CAPA, training records, PQR and departmental self-inspection program. As a member of the Supply chain team, you will be co-responsible for the site and the department results.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Ensure on time management of quality system workload through mentoring, training and coaching of Supply chain staff associated with Quality System tasks as well as through work load distribution and tracking against applicable time lines.

• Ensure all validation, quality, safety and environmental procedures and regulations are met, maintained and documented appropriately.

• Responsible for KPI adherence of Quality System metrics.

• Perform as department SME on deviation investigations, ensuring root cause analysis, FMEA's and collaboration with Industrial Excellence team is in use and in place.

• Lead cross functional team when required.

• Understanding potential fail mode outside of Marietta control and identifying correct contact for updates and problem resolution

• Ensure robust departmental attention / prioritization of CAPAs, Change Controls, LICs, quality escalations, quarterly reports, departmental audits, customer complaints, and PQRs.

• Track, trend, and evaluate manufacturing discrepancies and work to determine root causes. This includes tracking and trending using a visual factory.

• Write and revise standard operating procedures, validation documents and other technical documents - ensuring alignment to QMS structure and SME input.

• Interact cross functionally with site support functions as well as Global partners to support the execution and closure of Quality System tasks.

• Interact with external regulatory authorities as needed during routine and non-routine audits.

• Demonstrated familiarity and compliance with cGMP's, EHS procedures and regulations, facility regulatory guidelines, and standard operating procedures

• Provide classroom training to Supply chain operations as requested.

• Develop internal audit schedule (including area to be audited) on a yearly basis and communicates the schedule to the site Quality organization. Interact with external regulatory authorities as needed during routine and non-routine audits.

• Represent the manufacturing department at the site change control and Quality Systems meetings.

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree

• 3 years pharmaceutical industry experience

• 3 years pharmaceutical experience investigating manufacturing deviations either in a QA or manufacturing role.

If you have the following characteristics, it would be a plus:

• Excellent organizational skills and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy.

• Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.

• Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.

• Demonstrated problem solving and investigational skills.

• Ability to communicate both verbally and in writing with all levels both inside and outside of the organization. The ability to clearly write technical documentation as necessitated by regulatory agencies an internal policy.

• Ability to establish and maintain working relationships with staff and the agility to analyze data and implement changes.

• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA. Ability to work in a high complex matrix environment.

• Prioritize and decide appropriate course of actions and to effectively implementing decisions.

• Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.

• Maintain attention to detail while executing multiple tasks.

• Perform job duties with minimal supervision.

• Sense of urgency, flexibility and accountability.

• Intermediate computer skills required included SAP

• Stay current on developments in the field and GSK-Bio Standards.

• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.