Senior Specialist Quality Assurance

Location
Cambridge, MA, United States
Posted
Sep 19, 2018
Ref
R-00323
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Senior Specialist Quality Assurance

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary

This position is responsible for the quality oversight of GMP Liposomal Manufacturing Operation and as needed Quality Control activities at IPSEN. The successful candidate will support daily manufacturing activities in both commercial and clinical settings. The candidate should be expected to leverage training, experience and technical knowledge to manufacturing and support groups on a routine basis, influencing a fast-paced dynamic environment to address quality concerns appropriately. This includes appropriate interpretation and use of existing quality systems and practices.

In addition, the candidate will be asked to support other vital QA areas such as validation, training and facilities as required.

Essential Functions
  • Interfaces and Influences all Manufacturing areas to continually improve quality at IPSEN
  • Perform real-time batch record reviews as assigned
  • Review and approve Quality Incidents pertaining to the manufacturing area and QC area as needed
  • Review and approve CAPA related to the manufacturing area and QC area as needed
  • Review and approve Change Controls to the manufacturing area and QC area as needed
  • Leverage quality systems QI(deviation), CAPA, Change Control, to support lot release and continuous improvement
  • Working with key stake holders Initiate and support the closure of the above systems
  • Prepare lot packets (compilation) for the disposition process
  • Review of Certificate of Analysis in support of lot release
  • Support the lot disposition schedule in accordance with Supply Chain
  • Resolves manufacturing issues as they arise in an efficient and effective manner
  • Performs walkthroughs and audits as required
  • Supports additional QA tasks or participates in projects as assigned which could include Quality Systems support, Inspection readiness activities, metrics.
  • Reviews and supports the method validation activities including protocols and final reports
  • SOP review and approval as needed
  • Logbook review as required


Qualifications

Education
  • B.S. Degree, in Life/Health Sciences, preferred.


Technical Experience:
  • Minimum 7+ years Quality Assurance GMP experience in the pharmaceutical/ biotechnology industry (commercial experience preferred)
  • Experience in QA oversight of Manufacturing preferred
  • A thorough understanding of FDA, EMA and ICH quality regulations
  • Proficient in MS Office applications and electronic document management systems
  • Experience in aseptic processing, monoclonal antibody production or nanoliposomal drug manufacturing is a plus


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.


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.