Position Details:
Location Lexington, MA
Job Title QA/QC Specialist 1
Duration 6+ Months
Must have skill-set [Job Description] Job Function and Description:
To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP and perform GMP release of IMP and to ensure compliance with market regulations.
Responsibilities
• To provide QA support for the manufacturing, packaging and control of clinical trial materials to ensure compliance with GMP and CTA requirements.
• Actively participate in project meetings as required.
• To be knowledgeable about the products supplied for clinical trials.
• Ensure complaints and deviations are fully investigated and documented. Release supplies in CSMD where appropriate.
• Ensure that all appropriate batch related documents are available in order to release the products.
• To communicate with contractors/suppliers regarding technical information and queries.
• Ensure the documentation systems to support Clinical QA Release activities are maintained.
• Prepare and/or update standard operating procedures and to ensure all Clinical QA SOP’s are reviewed in a timely manner.
• Ensure that GMP training is current and completed on time.
Education and Experience Requirements
• Degree or equivalent in Chemistry, Biology, Pharmacy or other relevant sciences.
• Practical experience of at least1 years in a QA environment in the pharmaceutical industry (in a clinical manufacturing/packaging environment preferred)
• Practical analytical experience desired.
• Good understanding of GMP regulations (FDA , EU, JP, etc.)
Thanks!!!
Warm Regards,
Amrit Singh
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Tel: (732) 429 1634
Fax: (732) 549 5549
http://www.irionline.com
Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70