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Description

Position Summary The Quality Control Analyst II will be responsible for supporting the manufacture of AAV Viral Vector Gene Therapy Drug Products through the performance of Analytical/Bioanalytical testing of starting materials, in-process/finished drug product, stability samples, as well as process characterization and development projects. Essential Position Requirements • Performs Analytical/Bioanalytical testing of starting materials, in-process/finished drug product and stability samples, primarily utilizing analytical test methods, product and residual content assays, and/or other compendial methods as required. • Performs product characterization assays to support product development and PPQ campaigns. • Supports method qualification, method validation and transfer to the QC laboratories, as needed. • Monitors lab equipment for instrumentation issues or calibration needs. • Provides input and authorship of document revisions related to SOPs and Work Instructions. • Troubleshoot and resolve method and instrument issues to successful resolution. • Contribute independently to Laboratory Investigations, OOS/OOT results, Deviations, CAPA, and Change Control record closure. • Participate in cross functional teams for Operation Excellence, Root Cause analysis, and performance of risk assessments. • Provides training for other teammates in department on assays qualified to perform. • Maintain Analytical laboratories in a state of inspection readiness and compliance. • Cross-train to serve in Quality Control sample receipt and Contract Testing Lab management functions. • Maintain inventory of critical assay reagents and consumables. • Flexibility in following unique manufacturing campaign testing requirements that may include off-hour and weekend work.

Skills

Quality control, Gmp, chemistry, bioanalytical, analytical chemistry, product characterization, Microscopy, aseptic technique, assay development, product release, stability, Biologics, Cell Therapy, Gene Therapy

Top Skills Details

Quality control,Gmp,chemistry,bioanalytical,analytical chemistry,product characterization,Microscopy,aseptic technique,assay development,product release,stability

Additional Skills & Qualifications

Experience and Qualifications B.S. or AS. in a Life Sciences discipline preferred with at least 2-4 years of relevant experience working in a cGMP environment. Experience working in cGMP Quality Control, preferably in a Biologics or CGT setting. Solid scientific Knowledge and hands on lab experience with analytical methods, microscopy, and/or aseptic technique. Ability to independently perform experiments for assay development, product release/stability/characterization, support for project activities with minimal supervision. Understanding of Good Manufacturing Practices (cGMPs). Strong attention to detail and strong organizational skills. Proficient written and verbal communication skills in a team-oriented environment. Have the Knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational as well as routine quality tasks.

Experience Level

Intermediate Level

Job Type & Location

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

Pay and Benefits

The pay range for this position is $38.00 - $40.00/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 ROCKVILLE,MD.

Application Deadline

This position is anticipated to close on Jan 22, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.