QA/QC Specialist I - Job#:15-00472
Our client in Lexington, MA is looking for a QA/QC Specialist I. This is a long term consulting position. If interested, Please apply to this ad
Position: QA/QC Specialist I
Location: Lexington, MA
Job#:15-00472
Job Description:
Job Description Primary Role
to provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP. To perform GMP release of IMP and to ensure compliance with market regulations.
Responsibilities
45% 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
10% ensure that all appropriate batch related documents are available in order to release the products.
25% to communicate with contractors/suppliers regarding technical information and queries.
15% 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.
5% ensure that GMP training is current and completed on time.
Education and Experience Requirements
Minimum
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.)Estimated Salary: $20 to $28 per hour based on qualifications.
Position: QA/QC Specialist I
Location: Lexington, MA
Job#:15-00472
Job Description:
Job Description Primary Role
to provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP. To perform GMP release of IMP and to ensure compliance with market regulations.
Responsibilities
45% 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
10% ensure that all appropriate batch related documents are available in order to release the products.
25% to communicate with contractors/suppliers regarding technical information and queries.
15% 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.
5% ensure that GMP training is current and completed on time.
Education and Experience Requirements
Minimum
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.)Estimated Salary: $20 to $28 per hour based on qualifications.
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