QC Compliance Specialist

Business Introduction
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.
Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.


Position Summary
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.

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

• 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.

Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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.

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

• 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