Vacancy expired!
- As GMP Quality Assurance Officer, responsible for the day-to-day GMP quality assurance compliance activities including management of OOS, deviations, CAPA and change control documents, releasing reagents per established procedures, establishing quality standards relating to QA/QC to ensure that the organization meets applicable State, Federal and accrediting agency regulatory requirements.
- Actively monitoring changes in the Federal regulations and other accrediting agencies’ standards to ensure continued compliance with current regulations and standards and maintaining core competencies as a Quality Assurance Inspector.
- Responsible for writing, review and approval of Master Production (batch) Records, Standard Operating Procedures (SOPs), worksheets, forms, Specifications, Validation Protocols and reports, and Production Record Control systems to ensure compliance.
- The incumbent is responsible for evaluating and interpreting regulations and standards to determine applicability and for effectively communicating such applicability.
- The incumbent will perform routine audits and inspections to ensure compliance and provide written reports of such, ensuring appropriate responses and follow up.
- The incumbent must ensure issues of critical non-compliance are handled in an appropriate and timely manner.
- The incumbent is also responsible for maintaining a document management program for all forms, policies and procedures, SOPs for the HGCTF.
- Review and analyze data; summarize reports.
- Track and trend quality indicators for the HGCTF. Prepare, maintain and update technical protocols, manuals, worksheets, forms, SOPs and all such documents for the HGCTF.
- Responsible for the completion of special projects and duties as assigned. This position requires a high level of confidentiality and discretion.
- Bachelor of Science Degree or Master’s degree in Biology, Chemistry, or related field and a minimum of five years of GMP quality assurance experience, a higher degree (Ph.D. or Pharm D.) with knowledge about GMP QA.
- Previous experience directly involved with federal regulations regarding GLP and GMP.
- Strong interpersonal communication skills to interact with physicians effectively and diplomatically, staff, administration & sponsors.
- Demonstrated skill in gathering pertinent data, preparing narrative reports, statistical reports, charts, graphs, and tables.
- Demonstrated ability to carry out analytical tasks, to identify and define issues and alternatives, to resolve problems, and to draw logical conclusions.
- Demonstrated skill in reviewing data and material compiled by others for completeness and accuracy to ensure that incorrect/incomplete data is corrected.
- Ability to deal with and maintain confidential and sensitive information with discretion. Ability to determine what information is confidential and to protect the confidentiality of that information.
- Demonstrated skill in good decision making and taking appropriate action in situations where no established criteria exists or where answers to problems are not readily available.
- Ability to work on a diverse variety of projects simultaneously, organize multiple projects for efficiency and cost-effectiveness.
- Demonstrated skill in prioritizing workflow to meet deadlines, often under pressure of conflicting demands, while maintaining accuracy and effectiveness of work.
- On occasion, ability to work flexible hours. Ability to attend off-site staff meetings, conferences, and investigator meetings.
- Ability to write concise and accurate administrative reports, policies, procedures, and correspondence.
- Working knowledge of some medical and scientific terminology for protocol abstracting and conversation with research personnel.
- Demonstrated skill in records management. Skill in establishing and maintaining complex filing systems.
- Demonstrated skills with personal computers, spreadsheets, databases, and word processing applications for the maintenance of administrative records, analysis of data, and the preparation of reports.
- Demonstrated knowledge of FDA Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines.
Vacancy expired!