Alkermes
QC Analyst II must have broad knowledge of all the techniques within the laboratory required for the routine support of the microbiology laboratory operations. In this role the Analyst will be a fully functional member of the team responsible for testing, data entry and occasional review of data for finished product, in-process samples, stability samples, clinical materials and raw material release in a cGMP regulated environment
Responsibilities
Execution of microbiological tests including but not limited to bioburden, LAL, growth promotion, sterility, particulate profiling and microbial identification of bulk, raw materials, in-process material, components, clinical materials and finished product
If required, must be able to perform cGMP biological testing (bioassays, flow cytometry, qPCR, and ELISA), Review and data entry for testing results following GMP regulations into the electronic data management systems
Perform laboratory investigations for out of specification and/or out of trend results
Write change controls and work orders for systems and instrumentation changes
Creation/Revision of SOP’s, and other documents required to support testing and ensure compliance
Participate in non-routine projects, validations and method development to meet departmental and individual goals
The employee will be required to participate in an on call schedule for various shift, holiday, or weekend work as needed
Qualifications
Critical thinker, ability to identify issues and work quickly to bring resolution
Capable of managing/coordinating multiple priorities in a dynamic environment, while maintaining a professional demeanor
Understand common microbiological test instrumentation
Excellent organizational, planning and scheduling skills
Good verbal and written communication skills
Experience of Thermo Sample Manager LIMS or other applicable LIMS systems
The successful employee will have the ability to function in a microbiological laboratory environment; the employee should have no inhibitions regarding safely handling microorganisms present in the laboratory, aseptic gowning, and no health conditions that would prevent them from doing so
Optional
Hands on experience in flow cytometry, quantitative PCR, and other bioanalytical methods like ELISA is an added advantage
Ability to work safely; seek out and encourage safe practice
Ability to focus attention to details and ensure high quality workAbility to cope with a rapidly changing work environment
Self-starter that takes initiative to do work with minimal supervision
Time management skills, Commitment to teamwork, Commitment to continuous improvement
Effective communication with co-workers and supervisors
Bachelor’s in science, preferably in Biology / Microbiology / Biotechnology or Biochemistry, required
Onsite #J-18808-Ljbffr
Responsibilities
Execution of microbiological tests including but not limited to bioburden, LAL, growth promotion, sterility, particulate profiling and microbial identification of bulk, raw materials, in-process material, components, clinical materials and finished product
If required, must be able to perform cGMP biological testing (bioassays, flow cytometry, qPCR, and ELISA), Review and data entry for testing results following GMP regulations into the electronic data management systems
Perform laboratory investigations for out of specification and/or out of trend results
Write change controls and work orders for systems and instrumentation changes
Creation/Revision of SOP’s, and other documents required to support testing and ensure compliance
Participate in non-routine projects, validations and method development to meet departmental and individual goals
The employee will be required to participate in an on call schedule for various shift, holiday, or weekend work as needed
Qualifications
Critical thinker, ability to identify issues and work quickly to bring resolution
Capable of managing/coordinating multiple priorities in a dynamic environment, while maintaining a professional demeanor
Understand common microbiological test instrumentation
Excellent organizational, planning and scheduling skills
Good verbal and written communication skills
Experience of Thermo Sample Manager LIMS or other applicable LIMS systems
The successful employee will have the ability to function in a microbiological laboratory environment; the employee should have no inhibitions regarding safely handling microorganisms present in the laboratory, aseptic gowning, and no health conditions that would prevent them from doing so
Optional
Hands on experience in flow cytometry, quantitative PCR, and other bioanalytical methods like ELISA is an added advantage
Ability to work safely; seek out and encourage safe practice
Ability to focus attention to details and ensure high quality workAbility to cope with a rapidly changing work environment
Self-starter that takes initiative to do work with minimal supervision
Time management skills, Commitment to teamwork, Commitment to continuous improvement
Effective communication with co-workers and supervisors
Bachelor’s in science, preferably in Biology / Microbiology / Biotechnology or Biochemistry, required
Onsite #J-18808-Ljbffr