Contribute to outstanding innovation + Make braver choices
Specialist, QC Analytical(1st Shift)
Location: Parsippany
As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our 'people first' philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.
Summary:
To perform laboratory method validation, qualification and transfer activities. Perform qualification of compendia methods related to raw materials. Performroutine analysis of raw materials, packaging components, in-process materials, drug substance, finished goods and stability samples by appropriate Analytical or Wet Chemistry. Sample incoming materials for packaging and production. Work independently and assist Seniors when necessary.
Responsibilities:
Performs method qualification and participate in analytical assay transfer to ensure successful start-up of laboratory. Performs compendia method qualifications.
Executes analytical and wet chemistry methods using HPLC, FTIR, GC, UV-Vis, and other instrument. Execute stability program including pulling, testing and report generation. Perform routine water testing.
Monitor analytical instruments for preventative maintenance and calibration and ensuringconformance to specifications. Ensure that IQ/OQ/PQ of new purchased instruments are performed by the vendor in timely manner.
Troubleshoot instruments in the lab when necessary. Perform a thorough investigation for any lab event/OOS/OOT/OOE results.
Perform routine QC responsibilities such as sampling, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents, as needed.
Generate/Revise general (non-complex) procedures, protocols, and technical reports as needed.
Author test methods and specifications as needed.
Initiate and complete QA-Track records when required.
Sample incoming materials in warehouse. Test and release the incoming materials.
Monitor laboratory equipment for temperature, humidity, etc., and conformance to specifications.
Requirements:
Bachelor's degree in 4 year degree in chemistry, health sciences or other related field from an accredited college or university.
A minimum of 3-5 years in a GMP, QC Analytical Technician or in the biotechnology or pharmaceutical industry.
Working knowledge following Standard Operating Procedure (SOP) and analytical test methods and generally accepted laboratory practices.
Strong verbal and written communication with ability to communicate complex ideas and concepts.
Strong attention to detail, i.e. reviewing documentation for adherence to SOP format requirements; accurate data entry of documentation into a database.
Comfortable with computerized data storage programs such as GLIMs.
Flexibility in work schedule.
Ability to effectively negotiate and influence key partners and suppliers to meet requirements and commitments.
Ability to train and mentor colleagues.
Drive for Results.
Ability to stand on feet for up to four hours at a time.
Be able to lift, push, and /or pull up to 25 pounds.
Meet minimal visual acuity requirements necessary for quality assessments.
Join our team and you'll become part of a close-knit family - one in which you'll be listened to and your contributions valued. Surrounded by like-minded people, you'll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team.
We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
