QC Scientist II - Analytical Support

The QC Scientist II (Analytical Support) will provide technical input for analytical proposals, work statements, test methods, investigations, risk assessments, and client inquiries. You will uphold Current Good Manufacturing Practices (cGMP) while supporting the department in Commercial and Clinical Biopharmaceutical Manufacturing, adhering to Corporate Standards.

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 and assist in technical training for analysts, data reviewers, and investigation writers.
• Interface between departments during method transfer, qualification, and validation.
• Perform method risk assessments prior to validation activities and assist with method language and form optimization.
• Advise on language for CAPAs to ensure compliance with analytical methods, SOPs, site policies, and scientific robustness.
• 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, engaging with clients during method validation/transfer.
• Manage critical reagent changes and review/approve internal reference material qualifications and recertifications.
• Expand scientific, technical, and compliance knowledge by engaging with scientific literature, attending industry conferences, and completing relevant training.
• Participate in continuous process improvement initiatives and support site safety initiatives.

• Proven experience (3+ years) in a GMP facility (biopharmaceutical or pharmaceutical industry) in a quality control role.
• 1+ years of experience in a client-facing role aligned to Quality Control.
• Bachelors Degree in a Biological Science related field (preferably Chemistry, Biochemistry).
• Minimum of 1-3 years of HPLC/UPLC experience in the quality/analytical/pharmaceutical industry.
• Working knowledge of scientific principles for a wide range of analytical techniques.
• Knowledge of GMP regulations in cGMP manufacturing environments.

• Experience with a multitude of HPLC/UPLC assays such as SEC, CEX, Glycans, Peptide Map is a plus.
• Prior use of EMPOWER is preferred.
• Knowledge of US and international regulations and guidance applicable to clinical and commercial pharma/biopharma products.
• Strong interpersonal skills including active listening, conflict resolution, and the ability to influence diverse stakeholders.
• Proficient use of MS Excel, MS PowerPoint, MS Teams, and MS Word.
• Outstanding technical reading and writing skills.
• Familiarity with standard project management concepts, tools, and responsibilities.

This position involves a Monday-Friday schedule, with training hours from 8:00am-4:30pm. After training, there is flexibility to work from home as needed, and you may need to be available between 6am-8pm to accommodate international clients. The role requires desk work with occasional standing/walking, and you must be comfortable wearing Personal Protective Equipment (PPE) such as lab coats, gloves, eye protection, and safety shoes. You'll also have exposure to fumes, chemicals, acids, and bases. The work culture supports continual growth and learning in an empowering environment, offering resources and opportunities to make meaningful contributions.

Pay and Benefits

The pay range for this position is $35.00 - $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 Berkeley,MO.

Application Deadline

This position is anticipated to close on Aug 7, 2025.

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 ... for other accommodation options.