Bioanalytical Quality Assurance Specialist

1 week ago

Germantown, United States Pharmaron Full time
Job DescriptionJob Description

Position Description:

The Bioanalytical Quality Assurance Specialist plays a crucial role in ensuring compliance with regulatory standards and quality procedures within our organization. Responsibilities include conducting audits, providing guidance on quality issues, and contributing to continuous improvement initiatives to uphold the highest standards of quality in bioanalytical operations.

Primary responsibilities:

  • Ensure compliance with the Company's Health and Safety, and Radiation Safety Program.
  • Conduct audits of assigned aspects of the Company's regulated activities, excluding the Finance Department, and promptly report to Test Site Management any non-compliance to the Company SOPs, protocols, policies, or relevant regulations.
  • Identify critical non-compliances and report them immediately to the Study Lead, Director of Quality Assurance, and Test Site Management.
  • Provide guidance and support to assigned functions with regards to quality issues.
  • Schedule and execute audits of plans, data, and reports for accuracy and compliance for regulated studies.
  • Audit laboratory activities performed by operations to ensure compliance with quality standards.
  • Schedule and execute facility audits of equipment, systems, and processes in compliance with QAU SOPs.
  • Provide, track, and close written audit reports for all auditing activities.
  • Contribute to the Quality Assurance Metrics Report to Management.
  • Provide support for Regulatory and client inspections.
  • Adhere to the operations of the Quality Assurance Unit (QAU) and to make recommendations for further implementation or improvement of any of its systems.
  • Prepare standard operating procedures for use by the Company as required.
  • Assist the Company in meeting business objectives by demonstrating quality processes and continuous improvement activities to Sponsors.

Qualifications:

  • Associates degree (or equivalency of 60 or more college credit hours) in a related field plus 4 years of experience OR Bachelor of Science in a related field plus 2 years of experience working in the regulated pharmaceutical industry.
  • Experience working in a Contract Research Organization (CRO) Quality Department performing auditing tasks.
  • Knowledge of bioanalysis

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 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 Cell & Gene Therapy 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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