Quality Assurance Associate – GMP

Exton /

Full Time /


Absorption Systems provides analytical support for gene and cell therapy products through every stage of development and non-clinical testing services to pharmaceutical and biotech companies to support research and development of drugs, biologics, and medical devices. Absorption Systems is headquartered in Exton, PA. Currently we are seeking a Quality Assurance Associate for the Exton, PA location. This multi-faceted position will actively support Quality Systems and GMP practices throughout the contract testing facility.

Key Responsibilities:

  • Actively contribute to all Quality Systems such as Investigations, Change Control, Out-of-Specifications, CAPA, Raw Materials and Risk Management
  • Collaborate with other departments to fully support Equipment Qualification and Calibration programs
  • Involvement with controlled document systems, including authoring and revising SOPs
  • Lead or assist with continuous improvement initiatives across all GMP functions
  • Lead or assist in auditing and investigation activities, perform root-cause analyses, and help to develop corrective and preventative action plans
  • Preparation of trend reports across Quality Systems, as needed
  • Provide support during Regulatory inspections and client audits
  • Assist in maintaining the facility in an inspection ready state
  • Communicate effectively with co-workers, management and clients
  • Additional duties as required

Requirements and Expectations:

  • A Bachelor’s degree in Science, preferably in biology or similar field
  • 2 – 4 years of working within the pharmaceutical or biotechnology industry, in a GMP environment
  • Strong understanding of GMP
  • Quality Systems experience in GMP environment
  • An ability to organize, understand, and present complex scientific and technical information at a level that is appropriate for technical and non-technical backgrounds
  • Attention to detail and analytical thinking
  • Excellent communication and interpersonal skills
  • Excellent organizational skills
  • Experience in Regulatory Inspection participation a plus

Benefits

Absorption Systems cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:

  • Medical, Dental & Vision Insurance Plan
  • Health Reimbursement Account
  • Healthcare & Dependent Care Flexible Spending Accounts
  • Employee Life and AD&D Insurance
  • Voluntary Life/AD&D Insurance for Employee, Spouse & Child(ren)
  • Short & Long-Term Disability
  • 401k
  • Profit Sharing Bonus Program

About Absorption Systems

Absorption Systems, founded in 1996, assists pharmaceutical and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. Additionally, Absorption Systems goes deep into each of those areas, offering in vitro, in situ and in vivo models to assess the properties in question. The company’s mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies® platform, a suite of human cell-based test systems for drug transporter characterization, exemplifies Absorption Systems’ commitment to innovation and is soon to be an industry assay standard for in vitro drug interaction assessment. Absorption Systems has facilities in Exton, PA, San Diego, CA, and Boston, MA to serve customers throughout the world.

Alongside of our enthusiasm for science and research, we have a passion to see each and every one of our employees grow and succeed both personally and professionally. We encourage our employees to continually enhance their ability to contribute to the success of the organization and advance their careers. Absorption Systems is committed to creating an environment where individuals are encouraged to grow and work in collaboration with each other while being passionate about innovation. The professional culture of our organization is a goal oriented environment full of internally driven and motivated professionals. Our company is unique in the fact that there is freedom for autonomy to execute and the ability for each employee to grow in directions that align their individual aspirations with company growth.