QA Specialist I

WuXi Biologics Group; United States; On-site; USD 60,200 - 96,300; Full time

Job summary

A leading biopharmaceutical company is seeking an experienced QA Specialist to join their Quality Assurance team. The successful candidate will ensure compliance with regulatory requirements and company standards, focusing on material release processes, documentation, and training. Key responsibilities include performing material release processes, conducting sell bank release activities, and developing training programs for QA staff. Candidates should have a Bachelor's degree and proven QA experience, preferably in a GxP-regulated environment. The anticipated salary range is $60,200 to $96,300.

Qualifications

• Proven experience in a QA role, preferably in a GxP-regulated environment.
• Strong knowledge of regulatory requirements and industry standards.
• Ability to work independently and prioritize tasks effectively.

Responsibilities

• Perform material release processes, including review and verification of documentation.
• Conduct sell bank release activities, ensuring compliance with regulatory requirements.
• Develop and deliver training programs for QA staff and other departments as needed.
• Collaborate with cross-functional teams to identify and implement process improvements.
• Support audits and other activities as required.

Skills

Analytical skills

Problem-solving

Communication skills

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, etc.

Job description

QA Specialist I

Reports to: Quality Assurance Manager
Location: US-CRAN

Job Summary:

We're seeking an experienced QA Specialist to join our Quality Assurance team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and company standards, focusing on material release processes, documentation, and training.

Key Responsibilities:

• Perform material release processes, including review and verification of documentation
• Conduct sell bank release activities, ensuring compliance with regulatory requirements
• Develop and deliver training programs for QA staff and other departments as needed
• Provide original documentation support and ensure accuracy and completeness
• Offer additional support to various departments as per business requirements
• Collaborate with cross‑functional teams to identify and implement process improvements
• Support audits and other activities as required

Requirements:

• Bachelor's degree in a relevant field (Pharmaceutical Sciences, Chemistry, etc.)
• Proven experience in a QA role, preferably in a GxP‑regulated environment
• Strong knowledge of regulatory requirements and industry standards
• Excellent analytical, problem‑solving, and communication skills
• Ability to work independently and prioritize tasks effectively

Anticipated salary range: 60,200-96,300

An Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. The job description does not intend to list all duties; other duties may be assigned as needed.