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QA GMP Operations, Associate

Employer
Homology Medicines
Location
Bedford, MA
Start date
Jun 25, 2019

View more

Discipline
Engineering, Quality, Quality Assurance, Science/R&D
Required Education
Bachelors Degree
Position Type
Full time

Job Details

QA GMP Operations, Associate

Location: Bedford, MA

The QA Sr. Associate/Specialist will provide on the floor support to partner with manufacturing staff to establish a right-the-first-time quality culture, deliver real time batch record review and enable efficient issue resolution. The ideal candidate will thrive in a dynamic environment and will bring value by balancing quality and efficiency during day-to-day operations. This role includes: Quality oversight of manufacturing and testing operations, real time batch record review, timely resolution of quality system records, manufacturing start-up activities and ongoing facility support. This is a 4 day/10 hour shift position (Sunday to Wednesday or Wednesday to Saturday) with flexibility required during facility start-up.

Essential Functions and Duties

  • On the floor Quality presence during manufacturing operations from thaw to fill/finish
  • Champion a Culture of Quality and ensure a safe working environment
  • Batch record review and approval
  • Streamlined release of raw materials and single-use components
  • Quality System record (e.g. deviations, CAPAs…etc) support and resolution
  • Review and approve records related to Calibration/Maintenance, Materials Management, Change Management and Quality Control
  • Support tracking and trending of metrics critical to operations
  • Support inspections and partner audits

Skills and Experience

  • Bachelor’s degree in life sciences, engineering, or equivalent
  • Minimum 3 years (Sr. Associate) / 5 years (Specialist) of experience in the pharmaceutical or biotech industry in QA operations and direct experience working with Quality Systems, specifically batch record review and deviations/CAPAs
  • Direct experience with biologics Drug Substance and Drug Product manufacturing
  • Knowledge of GMP regulations and guidelines
  • Ability to problem solve and work autonomously in a dynamic manufacturing environment
  • Ability to apply a phase appropriate, risk-based approach to QA operational decisions
  • Excellent technical, organizational, communication and interpersonal skills are essential
  • Flexibility to accommodate to rapidly changing priorities and deadlines
  • Final Fill, packaging and labelling experience preferred
  • Auditing experience a plus

Interested candidates should forward a cover letter and Resume / CV

Homology Medicines, Inc. (HMI) has built foundational intellectual property on gene editing and gene therapy vectors derived from naturally occurring human adeno-associated viruses (AAVs). The Company's technology is precise, on-target and highly efficient for in vivo editing of genetic mutations. This transformative platform technology, combined with an elite leadership team of biopharmaceutical industry veterans, create a significant opportunity for HMI to rapidly advance a diverse pipeline of new medicines that address and potentially cure the underlying cause of genetic diseases.

Company


Homology Medicines is based on groundbreaking science that harnesses the naturally occurring process of homologous recombination. This non-nuclease-based approach offers clear advantages in its precision, efficiency and on-target in vivo editing of genetic mutations. Homology obtained an exclusive worldwide license to this technology platform, which is based on the pioneering research of Saswati Chatterjee, Ph.D., Professor of Virology at the Beckman Research Institute at the City of Hope in California, member of the Recombinant DNA Advisory Committee (RAC) to the Office of the Director, National Institutes of Health (NIH) and former charter member of the Therapeutic Approaches to Genetic Diseases Study Section of the NIH. Dr. Chatterjee and her team led the first adeno-associated virus (AAV) vector-mediated gene transfer studies into human hematopoietic stem cells and subsequently identified and isolated a series of naturally-occurring AAVs from human CD34+ cells.

YEAR FOUNDED:

2015

LEADERSHIP:

Founder: Saswati Chatterjee

President and CEO: Arthur Tzianabos, Ph.D.

CSO: Albert Seymour, Ph.D.

Company info
Website
Phone
857-305-1825
Location
1 Patriot Place
Bedford
Massachusetts
01730
US

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