Lead Analytical Scientist — QC & Method Dev (12-Mo)

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

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.