Performs testing to ensure cGMP compliance in the manufacturing
facility. Responsible for assessing the microbiological quality of
products, manufacturing equipment, manufacturing process areas, and
facility utilities. Lead-Related Activities include, but are not
limited to, the following:
? Provides on-the-floor guidance and support to employees.
? Ensures employees timesheets are completed on time.
? Monitors employees training to ensure that all requirements are
met, including OJT.
? Maintain up to date training records for self and direct reports.
? Perform monthly performance feedback meetings with direct reports.
? Escalates all performance issues to management and/or HR.
Duties and
_RESPONSIBILITIES_ include, but are not limited to, the following:
Microbiology representation and participation in cross functional site
meetings.
Administration of programs such as gowning, training, ordering,
calibration, etc.
Technical writing assignments such as SOPs, protocols, final reports,
trend reports, risk assessments, laboratory investigations, etc.
Participates in training of other new employees and prioritizes
workloads on a daily basis.
Performs peer review of data.
Performs laboratory investigation reports.
Performs microbial identification procedures. Maintains laboratory
supplies, media, and reagents inventory. Participates in the overtime
and weekend schedule as required.
Performs bioburden and endotoxin testing of products and raw
materials. Performs microbiological testing of in-process and final
product materials. Performs biological and endotoxin indicator testing
used in the validation of manufacturing equipment. Updates
microbiological environmental monitoring results database and prepares
monthly report. Performs acceptance testing of commercially prepared
microbiological culture media. Assists in coordinating equipment
maintenance and calibration. Uses Laboratory Information Management
System (LIMS) for sample and sample test result tracking.
Performs all duties relevant to the Quality Control Microbiology
Analyst position as required.
Education and
EXPERIENCE:
Requires BS/BA in Microbiology or related field and 1+ years of
relevant experience.
Or equivalent combination of education and experience. Summary:
Performs testing to ensure cGMP compliance in the manufacturing
facility. Responsible for assessing the microbiological quality of
products, manufacturing equipment, manufacturing process areas, and
facility utilities. Lead-Related Activities include, but are not
limited to, the following:
? Provides on-the-floor guidance and support to employees.
? Ensures employees timesheets are completed on time.
? Monitors employees training to ensure that all requirements are
met, including OJT.
? Maintain up to date training records for self and direct reports.
? Perform monthly performance feedback meetings with direct reports.
? Escalates all performance issues to management and/or HR.
Duties and
_RESPONSIBILITIES_ include, but are not limited to, the following:
Microbiology representation and participation in cross functional site
meetings.
Administration of programs such as gowning, training, ordering,
calibration, etc.
Technical writing assignments such as SOPs, protocols, final reports,
trend reports, risk assessments, laboratory investigations, etc.
Participates in training of other new employees and prioritizes
workloads on a daily basis.
Performs peer review of data.
Performs laboratory investigation reports.
Performs microbial identification procedures. Maintains laboratory
supplies, media, and reagents inventory. Participates in the overtime
and weekend schedule as required.
Performs bioburden and endotoxin testing of products and raw
materials. Performs microbiological testing of in-process and final
product materials. Performs biological and endotoxin indicator testing
used in the validation of manufacturing equipment. Updates
microbiological environmental monitoring results database and prepares
monthly report. Performs acceptance testing of commercially prepared
microbiological culture media. Assists in coordinating equipment
maintenance and calibration. Uses Laboratory Information Management
System (LIMS) for sample and sample test result tracking.
Performs all duties relevant to the Quality Control Microbiology
Analyst position as required.
Education and
EXPERIENCE:
Requires BS/BA in Microbiology or related field and 1+ years of
relevant experience.
Or equivalent combination of education and experience.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
