Quality Control Specialist

Quality Control Specialist – Sample Management and Technical Writer

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.
• 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 build strong working relationships across departments.
• Track record of driving continuous improvement initiatives to enhance efficiency, reduce deviations, and improve product quality.
• Strong organizational skills with the ability to manage multiple projects and timelines in a fast-paced environment.
• Excellent attention to detail, documentation accuracy, and commitment to data integrity.

Additional Skills & Qualifications

• Experience in bioanalytical and bioassay methods for monoclonal antibodies and other biologic molecules.
• Experience in biopharmaceutical, pharmaceutical, or biotechnology manufacturing, particularly in large molecule and bioprocess environments.
• Familiarity with aseptic techniques, cleanroom operations, and gowning procedures in a regulated manufacturing or laboratory setting.
• Experience with document control systems and structured management of SOPs, IOPs, EOPs, STPs, and other controlled documents.
• Exposure to production and bioprocess operations and an understanding of how QC supports end-to-end manufacturing.
• Experience supporting or authoring documentation for regulatory submissions, including prior approval supplements, renewals, and updates.
• Ability to analyze QC trends and metrics to identify systemic issues and propose process or system enhancements.
• Strong problem-solving skills with the ability to resolve technical issues in the laboratory and support troubleshooting of analytical methods.
• Experience working in or with global organizations and comfort operating within complex, matrixed environments.
• Interest in contributing to an innovation-focused culture that emphasizes scientific excellence, client service, and operational efficiency.

Work Environment

The role is based in a large molecule manufacturing environment that includes both the manufacturing floor and Quality Control laboratories. You work closely with biologics process development and production teams in a GMP-regulated setting, supporting biopharmaceutical and biotechnology operations. The QC lab operates under strict safety protocols, including aseptic techniques, cleanroom practices, and gowning procedures, with a strong emphasis on data integrity and compliance. The organization maintains a culture driven by passionate scientists focused on solving complex scientific problems, improving R&D productivity, accelerating time to market, and reducing innovation costs. Safety is central to operations, with shared responsibility and accountability for following safety guidelines, procedures, and SOPs. The environment offers exposure to advanced biologic analytical techniques, qualification and validation activities, and regulatory inspections, providing opportunities for professional growth in a dynamic and innovation-oriented setting.

Job Type & Location

This is a Contract position based out of Baltimore, MD.

Pay and Benefits

The pay range for this position is $36.00 - $36.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Baltimore, MD.

Application Deadline

This position is anticipated to close on Jul 31, 2026.