Lab Peer Reviewer
East Falmouth, MA East Falmouth, MA Full-time Full-time 4 hours ago 4 hours ago 4 hours ago PURPOSE:
Perform Peer Review/Scientific Review of BET, method development/validation of samples tested in CTS based on USP / standards, cGMP, and ACC standard operating procedures (SOP).
GENERAL
Responsibilities:
Scientific review of testing, results, and reports for each of the three LAL methods (gel clot, turbidimetric, and chromogenic) and Glucatell to ensure the original records were reviewed for accuracy, completeness, and compliance with SOP?s.
Peer review of monthly laboratory logs for accuracy, completeness, and compliance with SOP?s Be familiar with the quality policy for ACC.
Be familiar and follow the ACC safety policy.
Be familiar with and follow the standard operating procedures (SOP) for ACC.
Report preliminary results to clients following cGMP standards and ACC SOP?s and interact with clients for questions related to their preliminary results.
Proper documentation of interactions with clients.
Check standardization of CSE for gel clot, turbidimetric, and chromogenic methods.
Review data for compliance with FDA Data Integrity.
Prioritize report review based on customer needs Detect and troubleshoot errors and inconsistencies in data during analysis.
Review instrument audit trails.
Initial and date each data page during review.
Sign reports as the Peer Reviewer responsible for review of the records.
Attend training as scheduled by ACC.
Other duties as assigned.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Perform Peer Review/Scientific Review of BET, method development/validation of samples tested in CTS based on USP / standards, cGMP, and ACC standard operating procedures (SOP).
GENERAL
Responsibilities:
Scientific review of testing, results, and reports for each of the three LAL methods (gel clot, turbidimetric, and chromogenic) and Glucatell to ensure the original records were reviewed for accuracy, completeness, and compliance with SOP?s.
Peer review of monthly laboratory logs for accuracy, completeness, and compliance with SOP?s Be familiar with the quality policy for ACC.
Be familiar and follow the ACC safety policy.
Be familiar with and follow the standard operating procedures (SOP) for ACC.
Report preliminary results to clients following cGMP standards and ACC SOP?s and interact with clients for questions related to their preliminary results.
Proper documentation of interactions with clients.
Check standardization of CSE for gel clot, turbidimetric, and chromogenic methods.
Review data for compliance with FDA Data Integrity.
Prioritize report review based on customer needs Detect and troubleshoot errors and inconsistencies in data during analysis.
Review instrument audit trails.
Initial and date each data page during review.
Sign reports as the Peer Reviewer responsible for review of the records.
Attend training as scheduled by ACC.
Other duties as assigned.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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