Quality Control Specialist

Job Title:

Quality Control Specialist - Sample Management and Technical Writer

Job Description

This Quality Control Specialist role focuses on sample management and technical writing within a large molecule manufacturing plant. The specialist works hands-on in the Quality Control unit, coordinating QC samples for routine and qualification testing, supporting qualification studies through detailed report writing, and providing backup testing as needed. The role collaborates closely with QC Microbiology, Manufacturing, Quality Assurance, Regulatory Affairs, Supply Chain, and Biologics Process Development teams to ensure timely analysis, inspection readiness, and robust data integrity across all QC activities.

Responsibilities

+ Work in Quality Control operations, performing hands-on activities including handling QC samples for routine and qualification testing, technical documentation, and backup testing of QC samples.

+ Coordinate QC sample management, including receipt, verification, labeling, storage, and distribution of samples to relevant testing laboratories and functions.

+ Compile, organize, and trend test results to support qualification reports and other technical documentation required for large molecule manufacturing.

+ Review test records and associated documentation to ensure they are accurate, complete, and compliant with internal procedures and regulatory expectations.

+ Support and perform testing of QC samples as needed to meet project timelines and manufacturing schedules.

+ Collaborate with the Biologics Process Development team to plan and execute testing activities that support drug substance development and manufacturing.

+ Ensure that laboratory incidents, out-of-specification (OOS) results, out-of-trend (OOT) results, deviations, and client complaints related to QC testing are thoroughly investigated and documented.

+ Identify root causes for QC-related issues and implement effective corrective and preventive actions (CAPA) within agreed timelines.

+ Maintain and periodically review all QC documentation, including SOPs, IOPs, EOPs, STPs, and other controlled documents, in alignment with the documentation control system.

+ Ensure timely completion of QC activities according to project plans, and update work plans to accommodate changes in project scope, priorities, or timelines.

+ Adhere to ALCOA principles of data integrity and promote compliance with these standards among team members.

+ Participate in functional working teams to perform self-assessments of compliance with SOPs, Good Manufacturing Practice (GMP), and data integrity standards.

+ Support preparation, execution, and timely closure of audit action plans, escalating concerns and risks as appropriate.

+ Support investigations and closure of client and regulatory audit observations related to Quality Control activities.

+ Ensure laboratory safety protocols are followed at all times, including aseptic techniques, cleanroom practices, and gowning procedures, and resolve technical issues in the QC lab effectively.

+ Support preparation and maintenance of QC documentation used in regulatory filings, including prior approval submissions, renewals, updates, and supplements.

+ Monitor QC analytical trends, complaints, failures, deviations, and changes to identify opportunities for process, system, and product improvements.

+ Plan and manage QC analytical lab resources to support smooth day-to-day operations and meet business needs.

+ Contribute to a culture of quality, compliance, safety, and continuous improvement within the QC organization.

Essential Skills

+ Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.

+ 5-8 years of progressively responsible experience in Quality Control within biologics or pharmaceutical manufacturing environments, specifically supporting large molecule products.

+ Hands-on experience in Quality Control operations, including sample management, routine and qualification testing, and technical documentation.

+ Strong understanding of USDA and USFDA regulations, as well as ICH, EU, and Health Canada regulatory frameworks relevant to biologics manufacturing.

+ Knowledge of USP and other pharmacopeial standards applicable to biologics and large molecule products.

+ Working knowledge of biologic analytical techniques and validation of analytical methods.

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Experience with GMP environments, including adherence to Good Manufacturing Practice and data integrity standards such as ALCOA.

+ Proficiency in deviation management, OOS/OOT investigations, CAPA development, and change control processes.

+ Experience in technical writing for qualification reports, SOPs, and other regulated documents.

+ Demonstrated ability to support regulatory inspections and third-party audits from a QC perspective.

+ Experience working within established quality systems, including qualifications, validations, and product lifecycle quality management.

+ Proven ability to lead or coordinate cross-functional teams and…