Quality Control Analyst

Quality Control Analyst

The Quality Control Analyst will serve as a hands-on analyst and specialist within the Quality Control (QC) unit at a large molecule manufacturing facility. This role focuses on utility and environmental monitoring sample collection, basic QC testing, and analytical support to ensure inspection readiness and timely release of results. The analyst will work within the QC Analytical group and collaborate closely with QC Micro, Manufacturing, Quality Assurance, Regulatory Affairs, Supply Chain, and Biologics Process Development teams to support drug substance development, manufacturing, and regulatory compliance.

Responsibilities include:

• Work in Quality Control operations, focusing on taking samples of utilities such as water and gas, performing Environmental Monitoring (EM), and conducting basic QC testing on collected samples.
• Serve as the primary point for sample collection activities, ensuring accurate, timely, and compliant sampling of utilities and environmental conditions.
• Compile and organize test results to support qualification reports and other quality documentation.
• Review test records to ensure accuracy, completeness, and compliance with internal procedures and regulatory expectations.
• Support testing of QC samples as needed, including basic analytical and microbiological testing within the QC Analytical laboratory.
• Collaborate with the Biologics Process Development team to execute testing activities that support drug substance development and manufacturing for large molecule products.
• Support laboratory incidents, out-of-specification (OOS) results, deviations, out-of-trend (OOT) results, and client complaints related to QC testing, contributing to timely and thorough resolution.
• Ensure all documentation, including SOPs, IOPs, EOPs, and STPs, is periodically reviewed, updated, and maintained according to the documentation control system.
• Ensure timely completion of QC activities in line with project timelines and update work plans periodically to accommodate changes in project scope, priorities, or schedules.
• Adhere to ALCOA principles of data integrity and promote compliance with data integrity standards among team members.
• Participate in functional working teams to perform self-assessments of compliance with SOPs and data integrity requirements.
• Support and contribute to investigations related to QC testing, analytical issues, or quality events as needed.
• Ensure laboratory safety protocols are followed at all times and help resolve technical issues in the QC Analytical lab efficiently.
• Support QC Analytical documentation in regulatory filings, including prior approval submissions, renewals, updates, and supplements, as required.
• Support monitoring of QC analytical trends, complaints, failures, deviations, and changes to identify opportunities for process, system, and product improvements.
• Plan and help manage resources to support smooth operations within the QC laboratory.

Essential Skills include:

• 2–4 years of progressively responsible experience in Quality Control within biologics or pharmaceutical manufacturing environments, specifically supporting large molecule products.
• Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.
• Experience in basic QC testing within a laboratory environment.
• Working knowledge of biologic analytical techniques and validation of analytical methods.
• Experience working within quality systems, including qualifications, validations, and product lifecycle quality management.
• Experience with biologics and biopharmaceutical manufacturing processes.
• Experience in environmental monitoring and utility sampling, including water sampling and gas sampling.
• Knowledge of Good Manufacturing Practices (GMP) in biopharmaceutical, pharmaceutical, biotechnology, or biotech production settings.
• Familiarity with microbiology laboratory practices and aseptic technique.
• Experience working in cleanroom environments and following gowning procedures.
• Understanding and application of ALCOA principles of data integrity.
• Knowledge of change control processes related to QC activities and laboratory operations.
• Ability to support investigations of OOS, OOT, deviations, and complaints related to QC testing.
• Understanding of regulatory expectations from USDA and USFDA, ICH, EU, and Health Canada for biologics manufacturing.
• Familiarity with USP and other pharmacopeial standards relevant to biologics.

Additional Skills & Qualifications include:

• Experience supporting QC Analytical documentation for regulatory filings, including prior approval submissions, renewals, updates, and supplements.
• Experience monitoring QC analytical trends, complaints, failures, deviations, and changes to drive process and system improvements.
• Experience collaborating with cross-functional teams such as QC Micro, Manufacturing, Quality Assurance, Regulatory Affairs, Supply Chain, and Process Development.
• Experience in bioprocess or production environments within biologics or…