Posted in Software 30+ days ago.
This job brought to you by eQuest
Location: Conshohocken, Pennsylvania
Position Title: Scientist - Microbiology
Working Location: Pennsylvania
Employment Status: Part time
Required Experience: 1 year
Required Education: Bachelors
Travel Required: 0%
Provide microbiological testing of raw materials, finished products, EM, and utility samples. Tests include: Endotoxin, Bioburden, Sterility, Microbial Identification, and Growth Promotion. Review and Approve EM and Microbiology Data/Results in accordance with established timelines. Execute validation protocols and method transfers in support of site initiatives. Troubleshoot processes, methods, and instruments to optimize performance. Provide technical expertise to less experienced staff. Please note that this role is a job share working 20 hours a week.
• Adhere to all EHS policies. Promote Safety culture by on-time reporting of incidents, and identification of ZAPS and HAZ IDs.
• Perform cGMP testing of raw materials, utilities, bulk/finished products, and validation samples utilizing established methods. Examples of test types include: Endotoxin, Bioburden, Sterility, Microbial Identification, and Growth Promotion.
• Provide accurate results and interpret data in compliance with cGMP’s, procedures and all applicable regulations. Follow up on questionable results and notify QC Microbiology Supervisor in a timely manner.
• Perform environmental monitoring sampling in Building 40, as needed. Testing may occur on first and second shifts and may include weekend and/or holiday work
• Review EM data and Microbiology within established timelines.
• Ensure all equipment, supplies and reagents are available and in a GMP state to support testing that is right-first-time and on time. Execute reagent, standard qualifications as required.
• Perform data review/logbooks reviews; manage to ensure releases meet SLA timelines.
• Be SME for Microbiology tests/processes. Evaluate micro tests/processes, and optimize to incorporate GSK best practices, incorporate efficiency, and address regulatory gaps. Serve as SME during internal and external audits.
• Serve as project manager for Microbiology/QC projects. Work to identify tasks, schedules, and budget for project, and execute to plan. Provide routine updates on project status.
• Conduct analyst qualification/training of team.
• Participate in investigations and planned remedial actions for atypical events and/or results in order to support the timely resolution of investigations. Author associated documentation.
• Write, update, and review Laboratory Standard Operating Procedures, Analytical Methods, Specifications and other GMP documents. Execute validation protocols and reports and other equipment-related documents.
• Follow and work in accordance with company policies, SOPs and cGMP standards to ensure compliance with all applicable regulations. Maintain required records and logs.
• Carry out departmental duties as deemed appropriate by Supervisor/ Manager.
• Prior work experience and/or able to perform some or all of the following: Endotoxin, bioburden, sterility, growth promotion, microbial IDs.
• Versed in GMPs, FDA and other regulatory agency requirements. Ability to interface with regulatory auditors.
• Serve as an SME (subject matter expert) in technical areas in order to provide information to others.
• Prior experience using the United States Pharmacopoeia (USP) for QC testing guidance.
• The ability to communicate both verbally and in writing with all levels both inside and outside of the organization. The ability to clearly write documentation as necessitated by regulatory agencies and internal policy.
• Ability to establish and maintain working relationships with Site staff and the ability to analyze data and implement changes.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment. Ability to work in a high complex matrix environment.
• Able to prioritize and decide appropriate course of action and to effectively implement decisions.
• Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
• Training and work experience in data analysis in order to monitor and trend data preferred.
• Sense of urgency, flexibility and accountability.
• Must be a committed team player prepared to work in and embrace a team based culture.
• Intermediate computer skills required.
• Stay current on developments in the field and GSK-Bio Standards.
• Maintain attention to detail, while completing multiple or repetitive tasks.
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
• Willing to travel abroad for training purposes.
• Position may require employees to work in a rotational schedule. This schedule may include holidays, and weekends; over-time may be required.
• Bachelors in microbiology, biochemistry, or similar scientific discipline. Degree in other discipline if sufficient technical depth has been achieved from professional experience
• 1 year experience in a GMP/FDA regulated environment.
• 1 year experience in Quality Control environment in a microbiology/chemistry/biochemistry field.
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.