GLP QA officer -生物分析（大小分子）

职位类别： 质检员/测试员

Responsibilities / Duties:

Performs protocol, data, report, and in-lab phase inspections for a specific study type to verify conformance to applicable SOP and regulatory requirements.

Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.

Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records).

Notifies management of service failures.

Manages all aspects of personal, daily micro-scheduling, organization and prioritization related to a full workload.

Performs study sign-off including but not limited to QA statement preparation (internal/external) and report finalization.

Performs SOP reviews for specific study type.

Starts to participate in internal facility and supplemental inspections, under supervision.

Starts to deliver basic quality/regulatory training, under supervision.

Identifies opportunities for process improvement and harmonization efforts that promote best practices.

Performs other related duties as assigned.

Education / Qualifications

Bachelor of Science/Arts (BS/BA) degree; degree in a science field is preferred (e.g. chemistry, biology, animal science)

Experience

At least 2 years of experience as a quality auditor in a GxP-regulated environment or at least three years working experience in GxP regulated environment.

• 年龄要求： 不限
• 语言要求：不限