QC Lead Scientist

job summary:
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 the company, Round Rock Quality and Safety policies.

location: Round Rock, Texas
job type: Contract
salary: $40 - 50 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:



Purpose of the Position:

• Conduct work in a professional manner.
• Undertake an expanding range of analytical analyses in support of company 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 company processes and quality systems.
• Demonstrate an understanding of and work in accordance with company 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 company and regulatory requirements.
• Maintain the QC Laboratory in a state of audit readiness that includes a clean and organized work environment.
• Adhere to company quality requirements and perform work in compliance with policies and procedures, including controlled substance requirements.
• Perform Laboratory work in accordance with company safety policies and procedures.
• Actively improve and promote safety policies in the laboratory.

 
qualifications:



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 company products, their applications and requirements.
• Understanding of company 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 company 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.

skills: Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Quality Control (QC)




Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on us.fitly.work.




Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).




This posting is open for thirty (30) days.