QC Scientist II - Analytical Support

Job Description

Job Description

QC Scientist II - Analytical Support

Job Description

The QC Scientist II (Analytical Support) will play a critical role in providing technical input for analytical proposals, work statements, test methods, investigations, risk assessments, and client inquiries. This position requires adherence to Current Good Manufacturing Practices (cGMP) in support of Commercial and Clinical Biopharmaceutical Manufacturing.

Responsibilities

• Provide technical input for analytical proposals, work statements, test methods, investigations, risk assessments, and client inquiries.
• Collaborate cross-functionally to develop and implement departmental policies and procedures.
• Assist in technical training for analysts, data reviewers, and investigation writers.
• Serve as an interface during method transfer, qualification, and validation processes.
• Perform method risk assessments prior to validation activities and assist with method language and form optimization.
• Advise on Corrective and Preventive Actions (CAPAs) to ensure compliance with analytical methods and site policies.
• Participate in FDA inspections, ISO and customer audits, and support external audit response management for analytical concerns.
• Attend new client meetings and on-site visits with high involvement during method validation/transfer.
• Manage critical reagent changes and review/approve internal reference material qualifications and recertifications.
• Expand scientific, technical, and compliance knowledge through literature, conferences, and relevant training.
• Engage in continuous process improvement initiatives and support site safety programs.
• Perform other job duties as assigned.

Essential Skills

• 3-5 years of experience in HPLC/UPLC within the quality/analytical/pharmaceutical industry.
• Experience with a variety of HPLC/UPLC assays, including SEC, CEX, Glycans, Peptide Map.
• Prior use of EMPOWER software.
• Knowledge of GMP regulations in a cGMP manufacturing environment.
• Strong in analytical chemistry and wet chemistry.
• Experience with ICH and FDA guidelines.
• Proficient in MS Excel, MS PowerPoint, MS Teams, and MS Word.
• Outstanding technical reading and writing skills.
• Knowledge of various analytical techniques: capillary electrophoresis, UPLC/HPLC, ELISA, and cell-based assays.
• Understanding of US and international regulations for pharma/biopharma products.
• Strong interpersonal skills for effective stakeholder influence.

Additional Skills & Qualifications

• Bachelor’s Degree in a Biological Science-related field, preferably Chemistry or Biochemistry.
• Experience in a GMP facility within the biopharmaceutical or pharmaceutical industry.
• 1+ years of experience in a client-facing quality control role.
• Familiarity with standard project management concepts and tools.
• Ability to inspire innovation and team effectiveness.

Work Environment

This position operates from Monday to Friday with a training period of three months from 8:00 am to 4:30 pm. Post-training offers flexible start times covering core hours from 9:00 am to 3:00 pm. The role is primarily desk-based, with 10% standing or walking and 90% sitting. Personal Protective Equipment (PPE) such as lab coats, gloves, eye protection, and safety shoes are required. Exposure to fumes, chemicals, acids, and bases is a part of the work environment.

This is a Contract to Hire position based out of Berkeley, MO.

The pay range for this position is $32.00 - $38.46/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 Berkeley,MO.

This position is anticipated to close on Jul 20, 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 View email address on ziprecruiter.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.