Job Description
Job Description
Position Description:
The Quality Assurance Associate will be responsible for upholding to quality standards at Pharmaron (Exton) Lab Services, by contributing to all Quality Systems within GMP Operations and reviewing quality data.
Primary Responsibilities:
Perform client data review and data pack assembly.
Serve as primary resource for the Raw Material Program, receiving, quarantining and release materials for use by the laboratories.
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, revising and approving SOPs.
Lead or assist with continuous improvement initiatives across all GMP functions.
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.
Candidate Requirements:
A Bachelor's degree in Science, preferably in biology or similar field
At least two years of working within the pharmaceutical or biotechnology industry, in a GMP environment
Strong understanding of GMPs
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:
Pharmaron 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 with Employer Contribution
Health Reimbursement Account Funded by Employer
Healthcare & Dependent Care Flexible Spending Accounts
Employee Life and AD&D Insurance 100% Employer Paid
Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren)
Short and Long Term Disability 100% Employer Paid
401k with Employer Match
Employee Assistance Program
About Pharmaron
Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.
Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.
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