Quality Assurance Associate (Contract)

Pharmaron•Exton, PA

5d•Onsite

About The Position

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services. We're proud of the impact we make and just last year, we supported 887 discovery projects , 1,100+ CMC programs , and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers . To learn more, visit www.pharmaron.com .

Requirements

Bachelor's degree in biology, chemistry, or related field.
5 years of working within the pharmaceutical or biotechnology industry.
Experience writing and reviewing SOPs, Protocols, Summary Reports
Experience with regulated data review
Excellent interpersonal skills with ability to communicate and work with all levels of the organization.
Excellent technical writing skills
Meticulous attention to detail

Nice To Haves

This position may require occasional travel to visit other US Laboratory and CGT sites, attend conferences, training, or meeting with team members, stakeholders, vendors or suppliers. The GMP QA Manager should be prepared for up to 10% travel as needed.

Responsibilities

Audit each GLP study at intervals adequate to assure the integrity of the study and maintain documentation of each audit.
Submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.
Ensure that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
Review the final GLP study report to ensure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the GLP study.
Prepare and sign a statement to be included with the final GLP study report which shall specify the dates inspections were made and findings reported to management and the study director.
Maintain the Master Schedule.
Prepare internal audit reports and communicate findings to internal stakeholders.
Provide suitable recommendations for internal audit observations.
Track audit responses and drive closure of CAPAs resulting from internal audits.
Identify the potential compliance issues and champion continual process improvement.
Provide support during Regulatory inspections and client audits.
Perform client data review
Serve as resource for the Raw Material Program, receiving, quarantining and releasing materials for use by the laboratories
Involvement with controlled document systems, including authorizing, revising, and approving SOPs.
Provide support during regulatory inspections and client audits