QC Scientist III - Analytical Support

Description

The QC Scientist III will be responsible for technical input for analytical proposals, work statements, test methods, investigations, risk assessments and client inquiries. The person will be responsible for following Current Good Manufacturing Practices (cGMP) while assisting the QC Analytical department in support of Commercial and Clinical Biopharmaceutical Manufacturing as mandated by Corporate Standards.

What will you do?

• Provide support for QC Analytical by performing the following: providing technical input for analytical proposals, work statements, test methods, investigations, risk assessments and client inquiries.

• Collaborate cross-functionally to identify, develop, strengthen, and implement departmental policies and procedures. Assist in technical training for analysts, data reviewers and investigation writers.

• Interface between AFS and QC Analytical during method transfer, qualification and validation. Perform method risk assessments for QC Analytical prior to validation activities. 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, advise, and support in FDA inspections, ISO and customer audits, and support external audit response management for analytical concerns.

• Attend new client meetings and on-site visits; high involvement with clients during method validation/transfer.

• Manage critical reagent changes, review/approve internal reference material qualifications and recertifications.

• Expand scientific, technical, and compliance knowledge by reading the relevant scientific literature, attending industry conferences and completion of relevant training

• Participate in continuous process improvement initiatives, provide support to site safety initiatives.

• Other job duties as assigned.

Skills

HPLC, GMP, chemistry, EMPOWER, Quality control, analytical chemistry, wet chemistry, cgmp

Top Skills Details

HPLC,GMP,chemistry,EMPOWER

Additional Skills & Qualifications

Education

• Bachelor’s Degree in a Biological Science related field (preferably Chemistry, Biochemistry)

Industry Experience

• Proven experience (3 years) related experience in a GMP facility (biopharmaceutical or pharmaceutical industry) in a quality control role.

• 1 years related experience aligned to Quality Control in a client-facing role.

Knowledge, Skills, Abilities

• Routine use of MS Excel, MS PowerPoint, MS Teams, and MS Word is crucial.

• Outstanding technical reading and writing skills.

• Background in analytical theory and technical competency of various biological and physical characterization techniques: capillary electrophoresis (cIEF/ICE, CE-SDS), UPLC/HPLC (excipient quantification, glycan analysis, proteolytic mapping, IEX, SEC), ELISA and cell-based assays (process impurities assessments and potency determinations).

• Knowledge of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to clinical and commercial pharma/biopharma products.

• Strong interpersonal skills including actively listening, conflict resolution and the ability to effectively influence diverse stakeholders for positive outcome.

• Ability to build strong relationships with client while instilling trust and confidence.

• Highly organized with attention to detail, proven time management skills with the ability to work on multiple projects simultaneously

• Familiar with standard project management concepts, tools and responsibilities (objectives, scope, results).

• Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.

Experience Level

Expert Level

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

The pay range for this position is $36.00 - $48.00/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 St. Louis,MO.

This position is anticipated to close on Apr 12, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $36 - $48