- Perform 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 instruments.
- Execute stability program including pulling, testing and report generation. Perform routine water testing.
- Monitor analytical instruments for preventative maintenance and calibration and ensuring conformance 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
- Must be able to be flexible with work schedule, as needed.
- 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 Techician or in the biotechnology or pharmaceutical industry
- Working knowledge following Standard Operating Procedure (SOP) and anlytical test methods and generally accepted laboratory practices
- Experience in Tech Transfer as well as routine Analytical testing related to Cell/Gene Therapy products.
- 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
- 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.
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specialist, qc analytical - Parsippany, NJ, United States - Ferring Pharmaceuticals, Inc.
Description
Job Description:
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and 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 plus commitment to science and research, Ferring is relentless in its 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.
As the Specialist, QC Analyst you will perform laboratory method validation, qualification and transfer activities. Perform qualification of compendia methods related to raw materials.Perform routine 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.
With Ferring, you will be joining a recognized leader, identified as one of The World's Most Innovative Companies by Fast Company, and honored by Fortune with inclusion on its Change the World List, for addressing society's unmet needs.
Ferring US is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country.
Responsibilities:
Requirements:
Requirements:
At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work.
From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our People First philosophy.
Our Compensation and Benefits
At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range.
The base salary range for this role is $60,000 to $85,000, which is the reasonable estimate of the base compensation for this role.
The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location.
Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.
Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year.
We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.
Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs.We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.
Join our team and your voice will be heard, and your contributions will be valued.If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.Location:
Parsippany, New Jersey
