QC Particulate Lab Techician

AMERICAN REGENT, INC.; Shirley (NY); On-site; USD 33,000 - 34,000; Full time

Job summary

AMERICAN REGENT, INC. in Shirley, NY is seeking a QC Technician to perform routine product-release testing per USP <788> and support non-destructive particle characterization and method development. The role includes data documentation, trend analysis, and assisting in equipment IQ/OQ/PQ.

The ideal candidate has a high school degree and up to 3 years in a QC lab, with aseptic processing experience preferred and willingness to work overtime as needed.

Qualifications

• Minimum of High School Degree required.
• 0-3 years in a Quality Control laboratory environment.
• Aseptic processing experience preferred.
• Ability to work overtime as needed.

Responsibilities

• Tracking/documentation of incoming samples.
• Prepare particle-free water for particulate analysis.
• Perform USP <788> Method 1 and 2.
• Perform Multisizer Analysis.
• Perform forensic testing on unknown particulate samples.
• Document all data generated from testing.
• Assist with data entry for analysis and trending.
• Order and track laboratory supplies.

Skills

USP <788>

Multisizer Analysis

Forensic testing

Data entry

Aseptic processing

Particle analysis prep

Education

High School Degree

Tools

Particulate matter systems

Job description

Nature and Scope

The QC Technician will be responsible for routine testing for product release by USP <788> and will play a supporting role in non-destructive (in vial) particle characterization, method development, routine testing for product release by USP 788 method 2 for opaque products, particle isolation, manipulation and particle forensics supporting product investigations, process evaluation, examination of customer complaint CRU, source particle characterization and mitigation programs, and R&D container closure studies.

Essential Duties and Responsibilities

• Tracking/documentation of incoming samples.
• Prepare particle-free water for particulate analysis
• Perform USP <788> Method 1 and 2.
• Perform Multisizer Analysis.
• Perform forensic testing on unknown particulate samples.
• Document all data generated from testing.
• Assist with data entry for analysis and trending.
• Order and track laboratory supplies.
• Clean and disinfect laboratory spaces/work areas.
• Assist in the characterization of particulate matter.
• Perform routine testing of final dosage forms and stability samples.
• Assist in the IQ/OQ/PQ of new laboratory equipment (e.g., new particulate matter systems).
• Assist in the performance of investigations.
• Maintain laboratory equipment (e.g., particulate systems, sonicator, laminar flow hoods).
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

• Minimum of High School Degree required.
• 0-3 years in a Quality Control laboratory environment.
• Aseptic processing experience preferred.
• Ability to work overtime as needed.

Physical Environment and Requirements

While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

Expected hourly range: $23.61 - $25.00 The hourly range displayed is the minimum and maximum hourly rate for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws.

FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fml...

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Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.