QA Lead Specialist
Sterling Life Sciences - Newark, NJ

This job posting is no longer available on CareerBuilder. Find similar jobs: QA Lead Specialist jobs - Sterling Life Sciences jobs

Partial Job Description
1) Provide support to the Quality Assurance Manager to ensure/follow up/implement corrective actions that are raised by deviations, internal audit or regulatory inspection
2) Direct quality systems, processes and procedures to ensure product quality and safety
3) Be responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs)
4) Develop and maintain policies and procedures for departmental functions
5) Influence site compliance with Quality Policy, Quality Management System Procedures, and Quality Star Guidelines
6) Influence participation in compliance to internal and external regulations
7) Influence quality system metrics such as Corrective and Preventive Action, Training Metrics, Completion and Complain Resolution Metrics
8) Evaluate clinical trial documents to ensure completeness, accuracy and conformance to GCP requirements
9) Define and perform audit of internal systems, investigator sites, CROs and CSUs supporting clinical trials and Pharmacovigilance
10) Prepare and issue GCP audit certificates for each audit conducted and found to be satisfactory
11) Provide QA support during regulatory authority inspections as applicable
12) Update key performance indicators/metrics in a timely manner
13) Interact regularly with the global clinical QA team, ensuring appropriate level of global standardization
14) Inform appropriate internal departments on audit results and work with the necessary staff to achieve GCP/GLP/PV compliance
15) Develop and maintain GCP/GLP/PV standard operating procedures in accordance with regulatory and company requirements
16) Contribute to the development of the annual audit plan to ensure compliance and provide ongoing update to adjust the audit plan
17) Provide oversight to external partners and vendors, which would require regular on-site visits
18) Act as project manager and manage projects assigned within the quality group
19) Respond at the initiation of the Quality Assurance Manager to any other special requests that may arise

Qualifications / Skills Required
1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people who have recent experience in Quality

CareerBuilder - 2 years ago - save job