Quality Control Analytical Scientist

Energy Jobline; Saddle Brook (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Quality Control Analytical Scientist to join their dynamic team. This role is essential in ensuring the proper execution of clinical analytical methods and supporting GMP testing. You will leverage your extensive experience in analytical chemistry and project management to mentor team members, write critical documentation, and implement continuous process improvements. If you thrive in a collaborative environment and are passionate about quality control in biotechnology, this opportunity could be your next career milestone.

Qualifications

• 8-10 years of experience in method development and validation.
• Direct GMP experience in QC laboratories.

Responsibilities

• Support internal and external customers for clinical analytical methods.
• Write documentation for Analytical Method Transfer and Validation.
• Train QC personnel during method transfer and validation.

Skills

Analytical Chemistry

Project Management

Flow Cytometry

ELISA

HPLC

Problem-Solving

Communication Skills

Education

B.S. or MS/Ph.D. in Analytical Chemistry

Tools

Statistical Tools

Job description

Job Description

Quality Control Analytical Scientist

Allendale, NJ

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical, and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a senior team member, the QC Analytical Scientist will be involved in various QC projects and should have a deep understanding of the general QC flow and the Product Cycle.

Responsibilities

1. Support internal and external customers to ensure proper and timely execution of all aspects of the clinical analytical method life cycle across clients.
2. Support routine GMP testing as assigned. Mentor and train team members.
3. Evaluate corporate and regulatory requirements and coordinate activities for their implementation.
4. Write documentation for Analytical Method Transfer and Validation life cycle, including master plans, protocols, test methods, and reports.
5. Create validation project plans, including timelines and resources, and provide status updates to management. Utilize statistical tools for evaluation and trending data.
6. Identify, evaluate, and implement continuous business process improvements.
7. Perform troubleshooting activities related to methods/assays, equipment malfunctions, and investigations (Deviations and OOS).
8. Provide support during laboratory investigations.
9. Train QC personnel during method transfer and validation. Support equipment qualification.
10. Maintain high documentation accuracy and clarity according to cGMP practices.
11. Set deadlines, prioritize work, and review/approve work performed by others for accuracy and compliance.
12. Potentially supervise cross-functional teams including product development, QA, PMP, and Manufacturing.

Requirements

• B.S. or MS/Ph.D. in Analytical Chemistry or related scientific field, with experience in QC laboratories for biotechnology products.
• 8-10 years of experience in method development, validation, and transfer.
• Direct GMP experience.
• Proficiency in project management tools and skills.
• Strong background in analytical chemistry techniques such as Flow Cytometry, ELISA, HPLC, CE, PCR, etc.
• Extensive knowledge of QC assay development, transfer, validation, and cGMPs.
• Attention to detail, analytical and problem-solving skills.
• Excellent communication skills, both written and verbal, across all organizational levels.
• Strong presentation skills and the ability to communicate effectively with upper management and teams.
• Ability to create and manage work plans, timelines, and handle competing priorities independently.
• Effective interpersonal skills for managing relationships and negotiating solutions.
• Familiarity with GMP lab environments and aseptic techniques.

Working Environment

Must be able to work in a team-oriented environment, including during weekends, holidays, or overtime as required. May be exposed to infectious diseases, hazardous materials, and chemicals, requiring proper PPE and safety protocols. Must be able to handle specialized equipment and work with moderate noise levels typical of manufacturing facilities. This description is not exhaustive and duties may change as needed.