Lead QC Scientist

Randstad USA; Round Rock (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

MilliporeSigma, a leader in life sciences, seeks a Lead Scientist (Analytical) to perform analytical testing on finished products, raw materials, and in-process samples. You will develop investigational strategies for OOS investigations, lead method development and validations, and ensure audit-ready QC operations.

You will maintain instrument qualifications, improve processes, and document work per regulatory and MilliporeSigma standards while upholding safety policies in a chemical-rich lab.

Qualifications

• BS or MS will have 4+ years prior work experience in a related field.
• PhD and no prior work experience.
• Knowledge of the ISO 9001, ISO 17025 and ISO 17034 requirements.
• May have prior work experience in a GLP, GMP and/or ISO environment.
• May have knowledge of quality system requirements of the medical device, pharmaceutical and/or clinical industries.

Responsibilities

• Perform analytical testing of finished products, raw materials, custom analytical projects, and in-process samples as directed in SOPs and methods.
• Develop and execute investigational strategies in OOS investigations and write OOS reports.
• Lead or participate in method development.
• Lead and participate in analytical method validations and technical studies.
• Perform instrument qualifications and maintenance/troubleshooting of analytical instruments.
• Lead or participate in improvement of processes, procedures and systems.
• Document work in accordance with MilliporeSigma and regulatory requirements.
• Maintain the QC Laboratory in a state of audit readiness that includes a clean and organized work environment.
• Adhere to MilliporeSigma quality requirements and perform work in compliance with policies and procedures, including controlled substance requirements.
• Perform Laboratory work in accordance with MilliporeSigma safety policies and procedures.
• Actively improve and promote safety policies in the laboratory.

Skills

Analytical testing

Technical writing

Problem solving

Education

BS in Chemistry

MS in Chemistry

PhD in Chemistry

Job description

***THIS IS A 12-MONTH CONTRACT WITH POSSIBILITY OF EXTENSION***

Who We Are:

MilliporeSigma is a leader in the life sciences. We aim to solve the toughest problems in the industry by collaborating with the global scientific community, and through that help increase access to health for people everywhere. We provide scientists and engineers with best-in-class lab materials, technologies, and services. We are dedicated to making research and biotech production simpler, faster, and more successful. At MilliporeSigma, we are with our customers at every step of the drug development process, shaping the possibilities for tomorrow.

Scope of Responsibility:

The Lead Scientist (Analytical) is responsible for performing analytical testing of finished products, raw materials, custom analytical services, and in-process samples. The Lead Scientist will use their experience and education to solve problems, optimize processes, develop new processes and methods, and assist in the development and analysis of new products. The Lead Scientist will also develop investigational strategies and participate in Out of Specification (OOS) investigations. All work is to be performed accurately and in compliance with MilliporeSigma, Round Rock Quality and Safety policies.

Purpose of the Position:

• Conduct work in a professional manner.
• Undertake an expanding range of analytical analyses in support of MilliporeSigma catalog, custom and new products.
• Lead or participate in technical problem solving, implementation of new processes and initiatives.
• Complete laboratory maintenance and housekeeping activities efficiently and in accordance with safety and quality policies and procedures.
• Complete laboratory equipment calibrations, verifications and maintenance activities on schedule with required documentation.
• Train on and demonstrate understanding of multiple analytical techniques.
• Participate in development of and demonstrate understanding of departmental goals.
• Demonstrate understanding of interdepartmental and MilliporeSigma processes and quality systems.
• Demonstrate an understanding of and work in accordance with MilliporeSigma’s safety policies.
• Work in accordance with documentation, quality and process policies and procedures.

Essential Job Functions:

• Perform analytical testing of finished products, raw materials, custom analytical projects, and in-process samples as directed in standard operating procedures and methods.
• Develop and execute investigational strategies in OOS investigations and write OOS reports.
• Lead or participate in method development.
• Lead and participate in analytical method validations and technical studies.
• Perform instrument qualifications and maintenance/troubleshooting of analytical instruments.
• Lead or participate in improvement of processes, procedures and systems.
• Document work in accordance with MilliporeSigma and regulatory requirements.
• Maintain the QC Laboratory in a state of audit readiness that includes a clean and organized work environment.
• Adhere to MilliporeSigma quality requirements and perform work in compliance with policies and procedures, including controlled substance requirements.
• Perform Laboratory work in accordance with MilliporeSigma safety policies and procedures.
• Actively improve and promote safety policies in the laboratory.

BASIC QUALIFICATIONS

Education:

• BS or MS or PhD in chemistry or relevant life science related field.

Knowledge and Skills:

Experience:

• BS or MS will have 4+ years prior work experience in a related field
• PhD and no prior work experience.
• Knowledge of the ISO 9001, ISO 17025 and ISO 17034 requirements.
• May have prior work experience in a GLP, GMP and/or ISO environment.
• May have knowledge of quality system requirements of the medical device, pharmaceutical and/or clinical industries.

Knowledge and Skills:

• The Lead Scientist has demonstrated knowledge and experience in analytical methods and interpretation of analytical results.
• Excellent verbal and technical writing skills. Ability to write procedures, reports, OOS reports, training documents, technical presentations, etc.
• Understanding of MilliporeSigma products, their applications and requirements.
• Understanding of MilliporeSigma quality system for ISO regulatory requirements.

ADDITIONAL LOCAL NEEDS

Environmental conditions:

Exposure to a variety of hazardous chemicals. Required to wear all personal protective equipment as described by MilliporeSigma procedures. This includes gloves, lab coat, safety glasses, respirators, face shields, and other PPE as pre-determined. Will be required to work with chemicals such as flammable solvents, carninogens, dioxins, and corrosives and general processing equipment.