Alkermes, Inc.
Team Leader, Quality Control (Microbiology)
Alkermes, Inc., Wilmington, Ohio, United States, 45177
Position Summary
The QC Team Lead will join the microbiology group to provide technical supervision, coordinate and track projects, act as point person on CMC Teams and validation projects. Responsibilities will also include reviewing, reporting test results as related to validation protocols. Direct Support for Method development and optimization for all Microbiology methodology and testing such as Endotoxin, Sterility, Biological Indicators, Microbial Limits, Bioburden. Suggest and implement new technologies and equipment for Microbiological testing.
Qualifications
A four year degree in science, preferably in Biology or Microbiology with minimum 8 years’ experience in the pharmaceutical industry
Experience with the execution of test methods for sterile and non-sterile drugs, raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters
Critical thinker, ability to identify issues and work quickly to resolution with minimum supervision
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
Good interpersonal skills and ability to work effectively in a team environment.
Commitment to continuous improvement in all areas.
Ability to work safely; seek out and encourage safe practices
Experience with LIMS systems, Trackwise or similar electronic documentation system, SAP
Major Responsibilities
Coordinate and support Tech Services Projects, which include:
Method Validations and optimizations
New technologies and equipment
Assist in the identification of new Microbiology testing technologies and equipment to meet evolving regulatory requirements.
Support regulatory audits.
Write protocols and execute method verification/validation/qualification/ transfers
Write, execute laboratory investigations for out of specifications and out of trend results
Point person and Microbiology point person for higher level meetings / projects such as CMC Team support.
Write documents (SOPs, specifications, technical reports)
Execute, oversee instrument qualification as necessary
Implement continuous improvement activities to maximize the resources available
Write change controls and work orders for systems and instrumentation changes
Review data as needed utilizing LIMS, SAP and SLIM
Troubleshooting of technical procedures, methodology and instrumentation
Data entry for testing results following GMP regulations
Review tests results for other analysts
Train new analysts and document training
Provide technical support to new analysts
Participate in non-routine projects, validations and method development to meet departmental and individual goals
Review SOPs, product specifications and controlled forms to comply with USP, EP, JP and CP regulations
Maintain the laboratory operations in compliance with industry regulations
The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills.
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Qualifications
A four year degree in science, preferably in Biology or Microbiology with minimum 8 years’ experience in the pharmaceutical industry
Experience with the execution of test methods for sterile and non-sterile drugs, raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters
Critical thinker, ability to identify issues and work quickly to resolution with minimum supervision
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
Good interpersonal skills and ability to work effectively in a team environment.
Commitment to continuous improvement in all areas.
Ability to work safely; seek out and encourage safe practices
Experience with LIMS systems, Trackwise or similar electronic documentation system, SAP
Major Responsibilities
Coordinate and support Tech Services Projects, which include:
Method Validations and optimizations
New technologies and equipment
Assist in the identification of new Microbiology testing technologies and equipment to meet evolving regulatory requirements.
Support regulatory audits.
Write protocols and execute method verification/validation/qualification/ transfers
Write, execute laboratory investigations for out of specifications and out of trend results
Point person and Microbiology point person for higher level meetings / projects such as CMC Team support.
Write documents (SOPs, specifications, technical reports)
Execute, oversee instrument qualification as necessary
Implement continuous improvement activities to maximize the resources available
Write change controls and work orders for systems and instrumentation changes
Review data as needed utilizing LIMS, SAP and SLIM
Troubleshooting of technical procedures, methodology and instrumentation
Data entry for testing results following GMP regulations
Review tests results for other analysts
Train new analysts and document training
Provide technical support to new analysts
Participate in non-routine projects, validations and method development to meet departmental and individual goals
Review SOPs, product specifications and controlled forms to comply with USP, EP, JP and CP regulations
Maintain the laboratory operations in compliance with industry regulations
The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills.
#J-18808-Ljbffr