QC Particulate Lab Technician

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

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• 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 Rate:

$23.61-25.50

The range, displayed is the minimum and maximum hourly rate of compensation 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/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

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

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·All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.

·Our recruiting process includes multiple in person and/or video interviews and assessments.

·If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.

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