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Job Title: Quality Control Analyst

Job Description

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

• 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

• 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

• 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.

Work Environment

This role is based in a large molecule manufacturing environment, with work performed both on the manufacturing floor and in the QC laboratory. The position involves regular utility sampling (such as water and gas), environmental monitoring, and work in cleanroom and controlled environments where aseptic technique and gowning procedures are required. The organization operates within a GMP-compliant biopharmaceutical and biotechnology setting, using established laboratory equipment and analytical technologies to support biologics production. The culture emphasizes innovation, scientific problem-solving, and close collaboration with global clients across pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries. Safety is a core value, with shared accountability for following safety guidelines, procedures, and SOPs at all times. The work environment supports cross-functional teamwork, continuous improvement, and adherence to data integrity principles and regulatory standar

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

The pay range for this position is $32.00 - $32.00/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)

This is a fully onsite position in Baltimore,MD.

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

About Actalent

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The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.