Quality Control Analyst

About the role

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.

Responsibilities

• 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.
• Plan and help manage resources to support smooth operations within the QC laboratory.

Essential Skills

• 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.
• Experience supporting 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

• 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 biotechnology.
• Experience in laboratory operations planning and resource management.
• Strong attention to detail and ability to maintain accurate and compliant documentation.
• Ability to work in a fast-paced, innovation-focused organization serving pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries.
• Comfort working in an environment that emphasizes safety, shared responsibility, and adherence to SOPs and safety guidelines.
• Strong communication and collaboration skills to support clients and internal stakeholders in resolving scientific and quality challenges.