Quality Assurance Associate (Contract)

Pharmaron Beijing Co. Ltd.; Exton (PA); On-site; USD 60,000 - 65,000; Full time

Job summary

Pharmaron Beijing Co. Ltd. invites applications for a Quality Assurance Associate to ensure GLP study integrity and regulatory compliance. The role audits study processes, data, and documentation and supports GMP activities within the quality group.

Responsibilities include conducting audits, reporting findings, maintaining schedules, and supporting regulatory inspections and client audits. Exton, PA on-site with a 6-month fixed-term contract and annual salary between $60,000 and $65,000.

Qualifications

• Bachelor's degree in biology, chemistry, or related field.
• 5 years of experience in the pharmaceutical/biotech industry.
• Experience writing and reviewing SOPs, protocols, summary reports.
• Experience with regulated data review.

Responsibilities

• Audit GLP studies at intervals to assure study integrity and maintain documentation.
• Submit written status reports to management and study director.
• Ensure deviations from approved protocols are properly authorized and documented.
• Review final GLP study reports for accuracy of methods and data.
• Prepare and sign statements for inclusion with final GLP study reports.
• Maintain the Master Schedule and internal audit reports.
• Provide recommendations for internal audit observations and drive CAPA closure.
• Support regulatory inspections and client audits.
• Perform client data review and manage Raw Material Program documentation.
• Involve in controlled document systems for SOP authoring, revision, and approval.

Skills

GLP audits

SOP writing

Regulatory data review

Education

Bachelor's degree in biology, chemistry, or related field

Tools

Document control systems

CAPA tracking systems

Job description

Position: Quality Assurance Associate

Salary Range: $60,000 - $65,000/year

Contract Duration: 6 months (fixed-term)

Location: Exton, PA (On-site)

About Pharmaron

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.

What You'll Do

The Quality Assurance Generalist is responsible for ensuring the integrity and regulatory compliance of non-clinical laboratory studies by conducting systematic audits of study processes, data, and documentation in accordance with Good Laboratory Practice regulations for and providing support for GMP activities within the quality group.

Key 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
• 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.

What We're Looking For

• 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

Why Pharmaron?

Pharmaron is a premier 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 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture:

You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

As an Equal Employment Opportunity and Affimative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.