- Assure testing priorities to support Manufacturing and Customer Service
- Establishes and implements appropriate training programs for the sites to provide micro awareness and coaching.
- Performs regular GEMBA-style assessments of the sites and performs routine audits of the manufacturing areas.
- Ensure data integrity and ensure GDP and GLP in the microbiology laboratory.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity, ability to recognize time sensitivity.
- Demonstrates strong knowledge of cGMP, ICH, FDA and compendial (USP, EP, JP) guidance.
- Strong knowledge of microbiological test methodology, environmental monitoring and industry-standard investigation process of any OOS that are related to microbial contamination.
- Reviews and provides oversight for microbial testing performed at contract labs.
- Extremely detail-oriented with strong analytical, verbal, and written communication skills.
- High level of ownership and accountability with strong ability of problem-solving
- Ensure test failures are investigated and documented as per regulatory guidance.
- Ensure implementation of effective CAPA based on root cause analysis.
- Prepare justification for new lab equipment. Prepare purchase orders and coordinate authorization and procurement. Arrange installation and qualification.
- Resolve test method issues which many involve interaction with customer and provide expert opinion
- Evaluate time and cost aspects of laboratory work associated with new product launce or new testing requirements.
- Provide microbiological technical support to validation projects.
- Ensure calibrations of lab equipment, documentation in logbooks and other GMP compliance activities are performed in the laboratory.
- Develop and implement ways to improve laboratory productivity, cost control and output.
- Review and approve SOP's, specifications, and other documentation required to administer the laboratory.
- Perform other duties as assigned.
- Experience in pharmaceutical product testing / Microbiology.
- Knowledge and experience with Total Quality Management and other quality management philosophies.
- Thorough understanding of Compendial test methodology applicable to microbiology.
- Fluency in written and spoken English
- Familiarity with LIMS and TrackWise
- Ability to use computer applications like Microsoft Outlook, Excel etc
- Ability to manage many diverse tasks and issues simultaneously, through prioritization, delegation, and "hands-on" personal effort in a fast-paced, high-volume environment.
- Understanding of laboratory safety requirements and the MSDS system.
- Ability to read, comprehend, and interpret technical data.
- Ability to represent Accupac to customers and regulatory agencies.
- Sitting for % of the work day.
- Walking/standing up to six hours each work day.
- Hear/Execute clear speech, in person and over the telephone.
- Lift/Carry items up to 40 pounds.
- Hear phones ring, alarms sound through ambient noise and everyday conversation.
- Possess color vision.
- Yes; Microbiologist
- None
- Bachelor's degree in a relevant discipline (Microbiology preferred).
- Minimum of five years management experience in the pharmaceutical industry within a Quality Control microbiology role.
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Manager - Microbiology Lab - Harleysville, United States - Accupac
Description
Accupac is hiring for a full-time Microbiology Lab Manager to join our Mainland PA. team.
Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description.
Job Summary:
The Manager, Microbiology Lab is responsible for managing all activities associated with the daily operations of the Microbiology Lab by leading a group of microbiologists. This role is responsible for effectively collaborating with multiple stakeholders to ensure Industrial Plant Hygiene, establishing, and publishing periodic reports on environmental monitoring and trending. This role will also support new product launches by reviewing product specifications, testing methodology, and providing guidance in test method verification and validation.
The Manager, Microbiology will have strong leadership and substantial experience in supporting the sites to be complaint with regulatory requirements in microbial control standards and procedures. This position will also play a critical role as SME in assisting audits.
Essential Duties and Responsibilities include but are not limited to the following:
Minimum Requirements of the Job:
Physical Requirements:
Supervisory Responsibilities:
Travel:
Education and/or Experience:
