We are looking for an experienced QC Microbiology Manager to consult for a client of ours in northern Indianapolis. Interested applicants must be local to the area and possess a strong QC Microbiology Management experience in Pharma and or Biotech, including environmental monitoring.

• Onsite 5 days a week
• 3-4 month contract with chance for extension
• Pay: Starting at $38hr

Summary: The QC Microbiology Manager manages the activities of a dosage pharmaceutical quality control unit in the performance and analysis under GMP conditions for the entire site. Scope of responsibility includes raw material, in-process and finished goods testing and release as well as stability requirements for finished packaged goods. It also includes Environmental Monitoring of controlled environments to assure controlled environments are maintained.

Responsibilities:

• Manage Microbiology/Environmental Monitoring Quality Control laboratories.
• Approve specifications, sampling instructions, test methods, procedures and other QC procedures.
• Approve and monitor any contract testing laboratory for compliance and test results.
• Ensure appropriate validations/qualifications are completed and approved.
• Ensure laboratory records are evaluated and signed by an authorized person before they are sent to the QA department.
• Ensure accountability, transparency, and effective communication cross-functionally and within the team while guaranteeing information is timely, clear and accurate.
• Ensure team compliance with all policies, procedures and site/company regulations.
• Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
• Exhibit accountability and responsibility for an area or process to affect change and lead efforts and ideas to completion.
• Provide leadership for employee relations through effective communications, coaching, training and development and eliminate roadblocks for the team to move forward.
• Supply the highest level of customer service while having the ability to challenge established procedures and systems.
• Lead team in continuous improvement activities.
• Ensure proper maintenance and cleanliness of the department, premises and equipment.
• Measure and communicate team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s).
• Maintain an acceptable level of 5S in the area. Assure the laboratories are maintained to promote an organized workspace.
• Lead and/or support all investigations. Review and approve area quality and safety exceptions and investigation reports. Ensure on-time completion of investigations and corrective action items assigned to area.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor Degree in scientific discipline required or equivalent work experience.
• 5 or more years Quality Control relevant leadership experience, with two or more years of experience in a management role; (preferably managing a team of ten or more multi-shift employees).
• Strong knowledge of cGMP requirements.
• Strong knowledge of laboratory equipment/product validation.
• Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories through hands-on experience working in a Pharmaceutical manufacturing facility laboratory.
• Expertise in the manufacture and control of finished products, analytical analysis techniques and statistical quality control.
• Working knowledge of regulatory (FDA, EU, ISO, USP, etc) requirements and applicable testing Guidelines. Background must include analytical method validation work.
• Thorough understanding of Quality systems such as validation, change control, deviations/non-conformances, and auditing.