Scientist, Quality Control

Amneal Pharmaceuticals LLC; Piscataway Township (NJ); Hybrid; USD 75,000 - 90,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Piscataway, NJ seeks a Scientist II - QC to perform testing of raw materials, in-process and finished products, including stability samples, and to report results under SOPs. The role supports method transfer and investigations to improve compliance and quality systems. Requires a BA/BS in Chemistry; MA preferred; 3+ years experience with QA/QC el.

Qualifications

• Requires a BA/BS in Chemistry or related science.
• MA/MS in Chemistry or related science preferred.
• 3+ years in testing of chemicals/pharmaceutical products with BA/BS.
• 1+ year in MA/MS testing of chemicals/pharmaceutical products.

Responsibilities

• Performs testing of raw materials, in-process and finished pharmaceutical dosage forms, including products on stability, according to written methods or compendial methods.
• Prepares samples for analysis with thorough cleanliness and complex steps for analysis using chromatographic techniques and writes laboratory records.
• Participates in method transfer activities between facilities or organizations.
• Investigates out-of-specification laboratory results when required.
• Performs physical analysis using X-ray diffraction, DSC, Malvern Mastersizer.
• Executes method transfer protocols and method verification/validation when required.

Skills

Analytical Testing

Calibration

Change Control

Data Entry

First Article Inspections

Good Manufacturing Practices

Hand Tools

Interpersonal Communications

Quality Management Systems

Regulatory Compliance

Troubleshooting

Education

Bachelor's degree in Chemistry or related science

Master's degree in Chemistry or related science

Tools

IR spectroscopy

UV-Vis spectroscopy

Chromatography

X-ray diffraction

DSC

Malvern Mastersizer

FT-IR

HPLC

GC

Dissolution apparatus

Job description

The Scientist II - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculating and reporting results on applicable specification documents, participating in method transfer activities within departments or between facilities or organizations. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.

Essential Functions:

• Performs chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques, adhering to company policies as identified in standard operating procedures (SOPs).
• Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analyzes. Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
• Actively participates in method transfer activities between facilities within the organization or between organizations.
• Actively participates in and leads investigation of out-of-specification laboratory results, when required.
• Performs physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer.
• Prepares and executes method transfer protocols, method verification/validation protocols as and when required.

Additional Responsibilities:

• Assists, as and when needed, senior scientists working in the laboratory.
• Ensures that expired chemicals and reference standards are removed from laboratory area, performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, GC as assigned by the supervisor.
• Standardizes API for use as in-house reference standard as assigned.
• Interacts with newly hired laboratory technicians or Assistant Scientists for providing hands-on training on simple analytical techniques and laboratory instruments.

Qualifications

Education:

• Bachelors Degree (BA/BS) Chemistry or related science discipline - Required
• Master Degree (MBA) Chemistry or related science discipline - Preferred

Experience:

• 3 years or more in Bachelors Degree (BA/BS) -Testing of chemicals/pharmaceutical products, 3 years or more
• 1 year or more in Master Degree (MA/MS) -Testing of chemicals/pharmaceutical products, 1 years or more

The annual salary for this position ranges from $75,000 to $90,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

Required Skills

• Analytical Testing
• Calibration
• Change Control
• Data Entry
• First Article Inspections
• Good Manufacturing Practices
• Hand Tools
• Interpersonal Communications
• Quality Management Systems
• Regulatory Compliance
• Troubleshooting (Problem Solving)

About Us

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.

Job Info

• Job Identification 8365
• Job Category Quality Control
• Locations 1 New England Avenue, Piscataway, NJ, 08854, US