Quality Control Specialist

Job Title: Quality Control SpecialistJob Description

The Quality Control Specialist will serve as an analyst/specialist within the Quality Control unit at a large molecule manufacturing plant. This role involves hands-on QC work, including handling QC samples for routine and qualification testing, report writing to support qualification studies, and backup testing of QC samples. The specialist will work collaboratively with various departments such as QC Micro, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness.

Responsibilities

• Manage Quality Control operations, including handling QC samples for routine and qualification testing, report writing to support qualification studies, and backup testing of QC samples.

• Coordinate sample receipt, storage, and distribution for relevant testing.

• Compile and organize test results to support qualification reports.

• Review test records for accuracy and completeness.

• Support testing of QC samples as needed.

• Collaborate with the Biologics Process Development team to plan and execute testing activities for drug substance development and manufacturing.

• Investigate laboratory incidents, out-of-specifications (OOS), deviations, out-of-trend (OOT) results, and client complaints related to QC testing.

• Implement corrective and preventive actions (CAPA) in a timely manner.

• Periodically review and update documentation, including SOPs, IOPs, EOPs, and STPs, as per the documentation control system.

• Ensure timely completion of QC activities according to project timelines.

• Adhere to ALCOA principles of data integrity for self and team compliance.

• Participate in functional working teams for self-assessment of compliance to SOPs and data integrity standards.

• Support preparation and timely closure of audit action plans and escalate concerns appropriately.

• Support investigations and closure of client and regulatory audit observations.

• Ensure lab safety protocols are followed and resolve technical issues effectively.

• Support regulatory filings, including Prior Approval Submissions, renewals, updates, and supplements.

• Monitor QC analytical trends, complaints, failures, deviations, and changes to identify opportunities for improvements.

Essential Skills

• Bachelors degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.

• 5-8 years of experience in Quality Control within biologics or pharmaceutical manufacturing environments.

• Understanding of USDA, USFDA, ICH, EU, and Health Canada regulations, as well as USP and other pharmacopeial standards.

• Experience supporting regulatory inspections and third-party audits.

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

• Leadership skills to lead cross-functional teams and foster a culture of quality and compliance.

• Experience in quality systems, qualifications and validations, and product lifecycle quality management.

• Proven track record in driving continuous improvement projects.

Additional Skills & Qualifications

• Experience in bioanalytical and bioassay methods for monoclonal antibodies and other biologic molecules.

• Ability to plan and manage resources for smooth operations in the QC analytical lab.

Work Environment

The work environment includes both the manufacturing floor and the laboratory, where safety is a shared responsibility, and adherence to guidelines, procedures, and SOPs is essential. The position involves working with advanced technologies and equipment to support the production and testing processes.

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.

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 Oct 14, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 [email protected] 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.