QC Analyst I/II

Company Name: Alkermes

Job Description

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 work.
• Ability 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.