Microbiologist Specialist - MSAT PC 1603

Miltenyi Biotec•Gaithersburg, MD

4d•$89,421 - $105,204•Onsite

About The Position

Your Role: This position will be in the Manufacturing Science and Technology team (MS&T) at Gaithersburg, MD site. This position is responsible for life cycle management of microbiological methods, worksheets and leading microbiological method related quality events (change controls, deviations, CAPAs). In addition, this position will support MSAT team to manage microbiological method changes, qualification of materials, supplier change notifications related to the microbiological testing methods. Additionally, the specialist will partner closely with internal and external stakeholders establishing partnerships to ensure compliance with cGMP and Quality Management systems to deliver our services to the clients effectively. Essential Duties and Responsibilities: Key Responsibilities: Investigate Deviations: Analyze and investigate deviations or out-of-specification (OOS) results from Environmental Monitoring (EM) and Microbiological testing to identify their true root cause. Change Management: Initiate/owns change controls or respective quality event to drive changes to the method, equipment, or material. Documentation: Maintain accurate, detailed, and objective documentation of all investigation findings, test results, and EM/Microbiological method SOPs in compliance with regulatory requirements. Root Cause Analysis: Utilize problem-solving tools like root cause analysis to determine the source of quality problems. CAPA Implementation: Collaborate with cross-functional teams to develop, implement, and track corrective and preventive actions (CAPAs) to prevent recurrence of deviations. Technical Support: Provide technical subject matter expertise in EM/Microbiological methods, instrumentation, and quality systems to support projects and resolve quality issues. Method Support: Troubleshoot EM/Microbiological methods and instrumentation and support method validation and implementation. Compliance & Audits: Ensure all activities comply with Good Manufacturing Practices (GMP), FDA guidelines, and other relevant regulations. Others: Communicate effectively with management and cross functional teams (e.g., present investigation findings at governance forums). · Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory and Quality teams. Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments. Prepare periodic reports and present data to internal and external stakeholders as needed. Knowledge management by preparing templates, procedures, and effective training to ensure process are effectively transferred to the operations team.

Requirements

Bachelor’s degree in Life Sciences and a minimum of 3 years of relevant and progressively responsible experience in these same areas
At least 3 years of related experience in a GMP biologics Quality Control environment.
Previous GMP experience in handling quality control related deviation, change controls, CAPA using appropriate quality system is required.
Strong knowledge of: Aseptic practices, Cleanroom behavior, Microbial techniques.
Worked in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory and Quality teams.
Demonstrated proficiency with regulatory requirements, USP, and ICH guidelines.
Experience in using the statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concepts required to evaluate trends.
Excellent communication skills with good technical writing skills with a proven ability to work with internal and external partners
Project management skills including planning, execution, risk and change management.
Effective team player.
Analytical skills with logical thinking problem solving skills.
Good knowledge of Microsoft office.
Work with operations team to create a culture of accountability, ownership, and continuous improvement.
Respect all safety, laboratory policies, and practices on site.
Work across departments and/or sites.
Work with process engineers and manager to align the priorities of the team with those of the department
Able to work independently; shows initiative and able to work with all levels of staff.

Nice To Haves

Prior handling of EM/Microbiological methods like is highly preferred.

Responsibilities

Analyze and investigate deviations or out-of-specification (OOS) results from Environmental Monitoring (EM) and Microbiological testing to identify their true root cause.
Initiate/owns change controls or respective quality event to drive changes to the method, equipment, or material.
Maintain accurate, detailed, and objective documentation of all investigation findings, test results, and EM/Microbiological method SOPs in compliance with regulatory requirements.
Utilize problem-solving tools like root cause analysis to determine the source of quality problems.
Collaborate with cross-functional teams to develop, implement, and track corrective and preventive actions (CAPAs) to prevent recurrence of deviations.
Provide technical subject matter expertise in EM/Microbiological methods, instrumentation, and quality systems to support projects and resolve quality issues.
Troubleshoot EM/Microbiological methods and instrumentation and support method validation and implementation.
Ensure all activities comply with Good Manufacturing Practices (GMP), FDA guidelines, and other relevant regulations.
Communicate effectively with management and cross functional teams (e.g., present investigation findings at governance forums).
Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory and Quality teams.
Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments.
Prepare periodic reports and present data to internal and external stakeholders as needed.
Knowledge management by preparing templates, procedures, and effective training to ensure process are effectively transferred to the operations team.