QC Specialist II (Equipment)

Location
Cambridge, MA, United States
Posted
Aug 20, 2018
Ref
477145
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
QC Specialist II (Equipment)

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary

Your primary responsibility will be the manage the operations and maintenance of QC equipment to support commercial operations and global product filings for liposomal cancer drugs. Additionally, you will participate in investigations and troubleshooting and collaborate with various other Ipsen teams and partner firms. It is expected that the Quality Control Specialist is able to work independently in the laboratory with minimal oversight.

Essential Functions
  • Manage the Empower Enterprise System which includes administrative functions and working with the vendor on troubleshooting
  • Analytical equipment management including scheduling all routine and non-routine maintenance.
  • Work closely with vendors on service contracts setup and management, and on troubleshooting software and hardware related issues.
  • Work closely with the Facilities/Engineering group for work orders and assets in the lab.
  • Work closely with the QA, Validation and IT for the setup of equipment and the associated software IQ/OQ and validation activities.
  • Write and manage all equipment related CAPA's and Change controls in QC


Qualifications

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


Technical Experience:
  • Minimum 5 - 7 years of experience in Analytical Equipment and software management.
  • Strong technical knowledge of Analytical equipment such as HPLC's with ELSD, UV, Fluorescence, and RI detectors, UV/Vis spectrophotometers, Malvern Particle size, TOC analyzer, and other standard wet chemistry equipment.
  • In-Depth knowledge of the Empower Enterprise software.
  • Demonstrated knowledge of current regulations, guidance, and compendia (e.g. 21 CFR 211, ICH Q2, USP & , and EP 2.2.46).
  • Demonstrated experience in GMP quality systems for continuous improvements, such as CAPA and Change Control.


Additional Qualifications:
  • Excellent technical writing skills and strong problem-solving abilities are a must.
  • Reliable and motivated with a desire to work collaboratively across teams and departments such as Quality Assurance, Validation and IT
  • Ability to work independently with minimal oversight and to act as a leader in the QC laboratory.
  • Excellent organizational and communication skills, both written and oral.
  • Working knowledge of computerized systems such as LIMS, etc. is a plus.
  • Ability to complete assigned projects and tasks within agreed deadlines.
  • Passion for science, learning, and fighting cancer.


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 Demands & Working Conditions
  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
  • Regularly required to operate standard office equipment (computer, copy/fax machine, etc.)
  • Ability to work on a computer up to 7 hours a day and occasionally sit or stand or walk for long periods of time
  • Ability to work in a dynamic environment which can include but not limited to office, laboratories, manufacturing, off-site venues, etc. depending on functional role.
  • Standard office environment. Potential interaction with laboratory environment with exposure to chemicals.
  • Close vision required for computer usage.
  • Occasionally required to stoop, kneel, climb and lift up to 30 pounds.
  • Required to consistently and properly use Personal Protective Equipment in keeping with Ipsen safety policies and practices.


Environmental, Health & Safety Requirements
  • Comply with all corporate and facility Environmental, Health and Safety policies and procedures. Attend all mandatory EH&S meetings and complete all EH&S training requirements.
  • Intervene in potentially unsafe situations and report any incident, unsafe acts, conditions or equipment. Report any emergency situation (medical emergency/chemical spill/security concern) by following established emergency programs and procedures.


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.