QC Compliance Specialist

GSK•Marietta, PA

7d•Hybrid

About The Position

You will serve as the Lead Investigator and SME for QC Deviations and Lab Investigations using the DMAIC process to investigate true root causes and identify CAPA to address them. Operate as back-up coordinator for QC Change Controls. Author QC Technical Documents, such as utility trend reports and deviation/event trend reports. Execute QS tasks as per established timelines. Identify, escalate, and support process improvement initiatives to reinforce a continuous improvement an audit readiness culture.

Requirements

Bachelor’s degree in a scientific discipline (for example chemistry, biology, biochemistry) or equivalent practical laboratory experience.
4+ years experience in a cGMP-regulated environment.
4+ years experience in a Quality Control environment in a Biochemistry, Chemistry, or Microbiology laboratory
Previous experience with UPLC/HPLC chromatographic analysis.

Nice To Haves

Experience with validation, calibration, or laboratory equipment/instrument maintenance.
Previous experience investigating Deviations and Laboratory OOS/Atypical/Invalid results and developing CAPA.
Working knowledge of pharmaceutical facilities and processes.
Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficent to apply to quality operations and compliance.
The 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 and internal policy.
Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes.
Must be able to address complex problems associated with assessing deviations, determination of root cause, and implementation of change and improvement to validated and/or FDA approved production systems.
Must have an aptitude for facilitating a team environment and working independently toward the goal of completing investigations.
Must obtain and maintain GSK Orange Belt certification to complete investigations following the DMAIC process
Participate in cross-functional deviations as needed.
Must have strong technical writing skills.
Demonstrated experience performing root cause analysis and writing investigation reports.
Working knowledge of current good laboratory or manufacturing practices and data integrity expectations.
Strong written and verbal communication skills to produce clear, concise documentation and interact with stakeholders.
Ability to work on-site or in a hybrid model as required by the site. This role may require on-site presence; the working arrangement will be confirmed during the hiring process.

Responsibilities

Investigate QC Deviations and OOS/Atypical/Invalid results using the DMAIC process to identify true root cause. Implement robust CAPA to eliminate/prevent/control the identified cause.
Ensure timelines are met for key deliverables (Deviations, Lab Investigations, CAPA, Change Controls).
Operate as the local SME for Lab Investigations at the site. Participate in global discussions on best practices and maintaining compliance.
Maintain QC Deviation/CAPA/Lab Investigation tier board by updating KPIs, keeping track of pending investigations, and providing updates to key stakeholders. Identify opportunities to enhance the tier board to improve communication and timely updates.
Champion for internal management monitoring audits for QC, responsible for QC's monthly audit completion and reporting the results to the QA Internal Auditor
Participate in internal and external audits as the SME on QC Deviations, Lab Investigations, and CAPA. Draft response letters addressing audit findings.
Work with cross functional teams to identify and support process improvement initiatives.
Trainer for Lab Investigation and root cause analysis for QC. Champion for GMP documentation and adherence to data integrity principles (ALCOA++) within QC.
Responsible for the on-time completion of MM audits, Utility Trend Reports, and Deviation/Event/Lab Investigation Trending.
Drive a strong safety culture within QC and the site. Adhere to all established EHS policies and procedures. Perform all tasks with a safety mindset following the EHS guidelines established on site.