Role = Microbiology Scientist
Duration = Start thru Project End of 10/31/21
Standard Day Shift (Mon-Fri; 40 hrs/wk; 8 hrs/day)
Marietta, PA - LOCAL CANDIDATES ONLY
• Provide microbiological testing of finished products, incoming materials, environmental monitoring samples, and utility samples. Tests include: Endotoxin, Bioburden, Sterility, Microbial Identification, Biological Indicator testing, and Growth Promotion. Review and Approve Microbiology Data/Results in accordance with established timelines. Troubleshoot processes, methods, and instruments to optimize performance. Provide technical expertise to less experienced staff.
Key Responsibilities (10 bullet points maximum)
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
• 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 utilities, bulk/finished products, and validation samples utilizing established methods. Examples of test types include: Endotoxin, Bioburden, Sterility, Microbial Identification, Biological Indicator testing, 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.
• Testing may occur on first and second shifts and may include weekend and/or holiday work
• Review 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.
• Become knowledgeable of Microbiology tests/processes. Evaluate micro tests/processes, and optimize to incorporate GSK best practices, incorporate efficiency, and address regulatory gaps.
• 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.
• B.S in Microbiology, Biochemistry, or similar scientific discipline.
• Prefer Minimum 1 year of experience in a GMP/FDA regulated environment.
• Prefer Minimum 1 year of experience in Quality Control environment in a microbiology/chemistry/biochemistry field.
Other Job-Related Skills/Background:
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.
• The ability to commuincate 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 agancies and internal policy.
• Ability to establish and maintain working relationships with Site staff and the abiliy 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.
ll qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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