长沙招聘

QA Specialist

Verify compliance to applicable Standard Operating Procedures (SOPs) and regulations by performing internal protocol, data, report, in-lab phase inspections, and supplemental audits, where applicable, in a technical discipline (e.g., Mammalian Toxicology, Bioanalytical Chemistry). In addition, the QA Specialist promotes expertise in achieving regulatory compliance and supports a second technical auditing discipline, or supports a specialized function (e.g., document control of SOPs/P&Ps, provide application support for site training/testing, provide training to new auditors, provide regulatory training). Cross-site support may also be provided for a technical discipline or specialized function. The auditor also performs facility audits in a technical discipline.

Responsibilities may include hosting client audits and leading process improvement activities and cross-site harmonization efforts.

Duties and Responsibilities:


Assists co-workers and internal customers with interpretation of regulatory requirements (e.g., GLPs), SOP requirements, and other guidance documents, as applicable.
Performs internal supplemental audits of a technical discipline to verify that facility records (e.g., equipment, training files) are in conformance to applicable SOP and regulatory requirements.
Performs internal protocol, data, report, and in-lab phase inspections in a technical discipline to verify conformance to applicable SOP and regulatory requirements.
Ensures systems used in QA are properly maintained (e.g., QA audit records, training records).
Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.
Supports a second auditing discipline, same auditing discipline cross-site, or specialized function (e.g., applications, document control of SOP/P&P, or auditor and regulatory training and development programs).
Performs facility audits in a technical discipline.
Promotes expertise in achieving regulatory compliance in a technical discipline by working with operations and scientific staff to resolve service/quality issues, serving on a committee, guiding the development of auditor and regulatory training programs, representing Covance at professional meetings, or other involvement.
Hosts client audits by establishing client contact, coordinating client agenda and other needs, leading the audit, preparing a written summary of findings, reviewing responses to client audit findings to assure accurate/complete, and communicating with other Covance business units to assure consistency.
Co-hosts regulatory inspections as needed.
Notifies management of observed quality/compliance trends and service failures.
Leads process improvement opportunities and harmonization efforts to promote best practices.
Facilitates changes to SOPs, policies, training materials, and other documents for a technical discipline.
Performs backup activities related to the local administration of eQA, eNotes when the local Administrator is unavailable.
Completes self-development opportunities.
Performs other related duties as assigned.


Education/Qualifications:



Bachelor of Science/Arts (BS/BA) degree.
Ability to efficiently use basic computer programs (e.g., Word, Excel, PowerPoint).
Experience may be substituted for education. For example, a two-year Associate degree plus 2 years applicable experience may be substituted for a BS/BA degree
Knowledge of GxP regulatory guideline.


Experience:



Two years of laboratory or related experience with a BS/BA degree.

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/