CAREERS
OPEN POSITIONS
Position: QA Specialist
Date Posted: February, 2010
Job Code: 3002
Reports to: PR
Position Requirements:
Provide assistance in the quality and regulatory oversight of Elusys service providers: contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs). Review of batch records (prior to finalization at CMO) and post-execution (prior to release of materials) for conformance to approved procedures and regulatory requirements. Position will also be responsible for supporting the following quality assurance functions.
Document and Change Control:
- Coordinate change control review at Elusys and communication with CMOs and CTLs
- Responsible for archival of all quality and regulatory documentation, including documentation provided by service providers, i.e., CMOs and CTLs
- Coordinate internal Elusys review of analytical reports including stability data, and release test data
- Responsible for archival of CTL data
- Assist review and approval of quality-related documents, including protocols, qualification, validation and stability reports, test results, including raw data, calibration certificates, temperature charts, clinical reports and assure compliance with appropriate FDA and ICH guidance documents
- Author, edit and/or review controlled documents such as SOPs, test methods, and protocols
- Maintain the review, approval and revision process for controlled documents
QA Compliance Oversight (internal / external):
- Coordinate Elusys’ review of deviations, failure investigations, out of specifications (OOS) results in a timely manner and communicate with service provider, as appropriate
- Responsible for quality oversight of CTLs
- Audit manufacturing and testing facilities for conformance to good manufacturing and laboratory practices (GMP and GLP), respectively
- Assure resolution of quality and/or compliance issues in a timely manner and effectively communicate with the contract service provider
- Assist in the quality oversight of internal Elusys activities
- Collaborate with Elusys lab staff to prepare laboratories (internal and CTLs) for potential Agency inspection(s)
- Facilitate Corrective Action Plans (CAPs) supervised by the QA Manager
- Coordinate tasks with applicable departments (internal and contracted) to effect the qualification and validation of test methods and the calibration and maintenance of laboratory equipment
- Coordinate communication between Elusys operations, regulatory, and clinical groups with external service providers, (CMOs and CLTs) supporting the release of clinical supplies
- Collaborate with applicable departments to monitor the inventory of clinical supplies and the reconciliation of any returned materials
Qualifications:
- Minimum of a bachelor’s degree in a biological science and 5+ years of experience within quality assurance
- Must have a demonstrated understanding and/or working knowledge of cGMP and GLP regulations
- Familiar with regulatory requirements inspections covering a broad range of compliance related issues, including but not limited to: research and development activities, process development and manufacturing of GMP materials, vendor qualification, and the qualification of analytical testing facilities
- Knowledgeable in GMP facility requirements, including but not limited to, equipment and facility design to meet regulatory requirements
- Knowledge of process and computer system validation
- Strong biologics experience, especially commercial facility inspection requirements for the production of biologics
- Demonstrated excellent interpersonal and communication skills, including the ability to influence and negotiate conflict resolution
- Desirable: Certified QA Auditor
If you want to work in a dynamic, challenging yet entrepreneurial environment, we invite you to review these exciting career opportunities.
Candidates please EMAIL your resume, with a cover letter referencing the job you are applying for, to info@elusys.com or fax it to 973.808.0322 attention Human Resources or mail it to Human Resource Department, Elusys Therapeutics, Inc., 25 Riverside Drive, Box 102, Pine Brook, NJ 07058.