• Company:
  MedFocus Pharmaceutical Research Opportunities
• Location:
  Princeton, NJ
• Status:
  Full Time
  Temporary/Contract/Project
• Education:
  Bachelor's Degree
• Industries:
  Biotechnology/Pharmaceuticals
• Occupations:
  Biological/Chemical Research
  Clinical Research
  Pharmaceutical Research
• Work Experience:
  2+ to 5 Years
• Job Category:
  Biotech/R&D/Science
• Career Level:
  Experienced (Non-Manager)
• Contact:
  John O'Grady
• Email:
  Apply by Email
• Reference Code:
  0000069977

Since 1993, MedFocus has succeeded in meeting the contract staffing needs of our consultants and clients faster and more effectively than our competition through "specialized" recruiting exclusively in the pharmaceutical arena. By staying focused, MedFocus has become the firm of choice for both client companies and our consultant job seekers.

QA Specialist

QA SPECIALIST COMPANY INFO: MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel. Our client is a leading provider of medicines to fight cancer, cardiovascular and infectious diseases -- including HIV/AIDS -- and serious mental illness and is seeking to add a QA Specialist to their team. RESPONSIBILITIES: •    Reviews in a timely manner, all batch and test documentation associated with investigational medicinal products (IMPs) packaging and clinical labeling and releases those for clinical use found in compliance into the SAPA and TrackWise® system. •    Supports, in a timely manner, the investigation of non-conformances and quality incidents. Resolves and documents into the TrackWise® system deviations or problems pertaining to the review of documents. Conducts appropriate follow-up, as required. •    Tracks deviation investigations and CAPA. Rejects packaged IMPs, or clinical labeling that fail compliance to GMP regulations and Company specifications and requirements. •    Ensure records relating to the package/labeling of IMPs and in compliance are submitted to the documentation center to be maintained in compliance with the record retention schedule. Review SOPs, WIs or other procedures as requested by supervisor. •    Contributes to training of group members as assigned by supervisor. Performs other duties as assigned by the supervisor QUALIFICATIONS: •    Strength in the qualification of analytical and microbiological laboratory instrumentation and equipment, computerized and non-computerized. •    Provide support to the Functional Area analytical instrument/ equipment qualification activities •    Review and approve pre-executed and post-executed Installation/Operational/Performance Qualification Protocols •    Review Instrument and equipment related Work Instructions for quality and compliance issues •    Familiarity with instruments, equipment and utilities supporting analytical laboratory operations (i.e. High Pressure Liquid Chromatograph, Gas Chromatograph, Atomic Absorption Spectroscopy, Ultra Violet Spectroscopy, Karl Fisher, Freezers, Refrigerators, Incubators, Water Systems, HVAC Units) •    Conduct review of documentation for compliance to Company and FDA regulated policies •    Review change control documentation for applicability to Company standards •    Communicate any identified or potential problems to Company supervisor •    Quality Assurance Specialist with combination of education, experience, and training to effectively review and approve Commissioning, Qualification, and Validation (CQV) lifecycle deliverables associated with facilities, utilities, equipment, instruments, and computerized systems supporting Investigational Medicinal Products and Clinical Supply Operations. •    Solid understanding of the CQV requirements pertaining to GMP regulated operations. Demonstrated knowledge and experience in application of industry accepted CQV standards and guidelines (ICH, ISPE, ISO, ATSM, PDA, GAMP 21 CFR 211, 21 CFR 11 etc.)   MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.