QC Assistant

Location
Cambridge, MA, United States
Posted
Sep 19, 2018
Ref
470431
Discipline
Quality, Quality Control
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
QC Assistant

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary

We are seeking a talented Quality Control Assistant to join our team in Cambridge! Your primary responsibility will be to support release and stability testing for a commercially approved drug for treatment of Pancreatic cancer. Additionally, you will participate in investigations and troubleshooting of aberrant data and equipment issues.

Essential Functions

Responsibilities

Responsibilities will include, but are not limited to, the following:
  • Perform testing and review of in-process, release and stability for lipids and small molecule products under cGMP.
  • Identify and assist in Troubleshooting aberrant data, maintain validated equipment and perform multiple HPLC based and wet chemistry analytical methods
  • Assist with guidance on investigations for Quality Instances, CAPAs, and Change Controls
  • Participate in OOS/OOT investigations and work cross-functionally with quality assurance, process development, manufacturing, and research and development


Qualifications

Education
  • BA/BS degree in Biochemistry (or a related field)

Experience
  • 1-2+ years of recent professional experience in a QC lab
  • Background in performingHPLC basedassays for proteins, lipids, and/or small molecules under cGMP
  • Demonstrated experience in GMP quality systems
  • Some Knowledge in most or all the following techniques: Particle Size, Peptide Map, Reverse Phase, SEC, CEX, SDS-PAGE, Bioanalyzer, pH, Osmolality and other standard wet chemistry methods.


Core Competencies
  • Ability to work with minimal supervision as well as in a team environment
  • Strongorganizational and presentation skills
  • Strong relationship, teambuilding, customer-focused orientation coupled with the ability to deliver results and meet or exceed agreed-upon objectives and timeframes:
  • Personal flexibility and a proactive orientation;
  • Ability to handle multiple priorities.
  • Ability to work under time and resource constraints.
  • Commitment to excellence and high standards.


Communication & Interpersonal Skills
  • Written: excellent
  • Verbal: excellent
  • Interpersonal: excellent


Other
  • Ability to work weekends pending business needs


Essential Functions - Physical Position Requirements: Machines and/or Equipment Used
  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
  • Regularly required to operate standard office equipment (personal computer, photocopy machine, fax machine, etc.)
  • Ability to work on a computer up to 7 hours a day.
  • Regularly required to sit for long periods of time, and occasionally stand and walk.
  • Regularly required to use hands to operate computer and other office equipment.
  • Close vision required for computer usage.
  • Occasionally required to stoop, kneel, climb and lift up to 25 pounds.


The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Ipsen Bioscience, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Bioscience, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.