Quality Control Analyst I

Description:

Quality Control Lab - Chemistry

Summary

Conduct specific chemical and physical analysis on medical devices through all stages of the manufacturing process from incoming raw materials to finished goods.

Essential Duties and Responsibilities

• Conduct critical chemical and physical analysis such as raw materials in-process and finished goods products samples at manufacturing facility.
• Use a variety of laboratory instrumentation KF Titrator DSC HPLC Particle Size Tensile Tester spectrophotometer and computer systems to collect and record data.
• Perform assays requiring precise analytical skills and understanding of chemistry principles.
• Complete all testing including special project / protocol testing in a timely and appropriate manner.
• Support laboratory equipment qualification Support test method validation Support laboratory investigation and conduct nonconformance investigation Maintain data integrity and ensure compliance with company SOPs and specifications FDA GLP QSR and cGMP regulations.
• Participate in functional efforts involving teams which impact production increase efficiency solve problems generate cost savings and improve quality.
• Perform laboratory preparation for internal/external audits as required.
• Perform equipment maintenance and calibrations as required.
• May perform other duties as assigned Weekend work may be required as needed to meet production timeline schedules.

Qualifications

• Ability to handle multiple tasks concurrently and in a timely fashion. Computer literate. Must be detail oriented conscientious and have high reading comprehension skills.
• Must understand laboratory instrumentation.
• Good interpersonal skills and be able to work effectively and efficiently in a team environment. Knowledge of cGMP manufacturing and GDP.
• Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: HPLC DSC KF Titrator etc.
• Knowledge of equipment qualification test method validation Knowledge of basic chemical and biological safety procedures.
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Must have passion to innovate and drive for solutions. Must display personal accountability for results and integrity.
• Must display eagerness to learn and continuously improve. Must have uncompromising dedication to quality

Education and/or Experience

Bachelors Degree in Chemistry or Biological Sciences with Analytical Chemistry or Laboratory coursework with 0-2 years experience.

Physical

• Regular attendance is necessary to perform the essential functions of the job.
• Light work frequent lifting up to 10 lbs frequent standing/walking.

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are 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.

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.