Quality Control Analyst

Quality Control Analyst The Quality Control Analyst (Sampler and Analyst) plays a hands-on role within the QC Analytical group at a large-molecule manufacturing facility. This position focuses on utility and environmental sampling, basic QC testing, and data integrity to support biologics drug substance development and manufacturing. The analyst collaborates closely with cross-functional teams, including QC Micro, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain, to ensure timely analysis, inspection readiness, and compliance with global regulatory standards. Responsibilities Perform day-to-day Quality Control operations, including collecting samples of utilities such as water and gas and conducting Environmental Monitoring (EM) activities. Serve as the primary resource for sample collection, ensuring accurate, consistent, and timely sampling of utilities and environmental areas. Conduct basic QC testing on collected samples and ensure results are accurate, reliable, and compliant with established procedures. Compile, organize, and maintain test results to support qualification reports and other quality documentation. Review test records to confirm they are complete, correct, and in compliance with internal procedures and regulatory expectations. Support testing of QC samples as needed to meet project timelines and manufacturing requirements. Collaborate with the Biologics Process Development team to execute testing activities that support drug substance development and manufacturing operations. Assist with laboratory incidents, out-of-specification (OOS) results, deviations, out-of-trend (OOT) findings, and client complaints related to QC testing. Ensure all documentation, including SOPs, IOPs, EOPs, and STPs, is periodically reviewed, updated, and maintained in alignment with the documentation control system. Complete QC activities according to project timelines and update work plans to accommodate changes in scope, priorities, or schedules. Adhere to ALCOA principles of data integrity and promote compliance with data integrity standards across the QC team. 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, deviations, and quality events. Ensure laboratory safety protocols are followed at all times and help resolve technical issues in the QC Analytical lab effectively and promptly. Support QC Analytical documentation for regulatory filings, including prior approval submissions, renewals, updates, and supplements. Assist in monitoring QC analytical trends, complaints, failures, deviations, and changes to identify and drive opportunities for process, system, and product improvements. Plan and manage QC laboratory resources to support smooth and efficient operations. Essential Skills Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline. 2–4 years of progressively responsible experience in Quality Control within biologics or pharmaceutical manufacturing environments, specifically supporting large-molecule products. Hands-on experience with basic QC testing in a laboratory or manufacturing setting. Working knowledge of biologic analytical techniques and method validation. Experience working within quality systems, including qualifications, validations, and product lifecycle quality management. Understanding of USDA and USFDA, ICH, EU, and Health Canada regulations relevant to biologics manufacturing. Knowledge of USP and other pharmacopeial standards applicable to biologics and pharmaceutical products. Experience with environmental monitoring in cleanroom or controlled environments. Familiarity with GMP practices in biopharmaceutical, pharmaceutical, biotechnology, or biotech manufacturing settings. Ability to follow aseptic techniques and cleanroom procedures, including gowning procedures. Experience with utility and water sampling and gas sampling in a regulated environment. Commitment to ALCOA principles of data integrity and accurate documentation. Ability to work cross-functionally with QC Microbiology, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain teams. Strong attention to detail, organizational skills, and ability to maintain complete and accurate records. Additional Skills & Qualifications Experience in bioprocess and production environments supporting biologics manufacturing. History in microbiology and laboratory operations within a QC setting. Familiarity with cleanroom operations and environmental monitoring technologies and equipment such as SAS, METONE, APEX, Dewpoint, and Draeger devices. Experience with change control processes and documentation within a quality system. Ability to support and participate in investigations related to QC testing, deviations, and quality incidents. Experience monitoring analytical trends, complaints, failures, deviations, and changes to identify continuous improvement opportunities. Strong problem-solving skills for resolving technical issues in the QC Analytical lab. Ability to plan and manage laboratory resources to ensure smooth QC operations. Comfort working in biopharmaceutical, pharmaceutical, biotechnology, and related scientific industries. Understanding of environmental monitoring concepts and practices in manufacturing and laboratory settings. Work Environment This role operates primarily on the manufacturing floor and in the QC laboratory within a biologics production facility. The work environment includes cleanroom and controlled areas where environmental monitoring and utility sampling (water, gas) are performed, along with basic QC testing. You will work with specialized monitoring and sampling equipment such as SAS, METONE, APEX, Dewpoint, and Draeger devices, following GMP, aseptic techniques, and gowning procedures. The culture emphasizes safety, scientific rigor, and collaboration, with shared responsibility for following safety guidelines, procedures, and SOPs. The environment is fast-paced and project-driven, supporting global discovery, development, and manufacturing activities for pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries. Job Type & Location This is a Contract position based out of Baltimore, MD. Pay and Benefits The pay range for this position is $32.00 - $32.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 Sep 17, 2026. Actalent