QC Metrology Supervisor

Simtra Bio Pharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement  hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The Quality Control Metrology Supervisor manages the activities in the QC Metrology department and the analysts that perform instrument maintenance and instrument projects in support of the company’s quality program. This role works as part of the quality control function, training, and leading others within the laboratory. This position reports to Quality Control Chemistry Manager.

• Manages the daily activities of the QC Metrology department.
• Ensure timely Metrology support to Production, QC Chemistry, QC Microbiology, QC Critical, Incoming Quality Control and other current Good Manufacturing Practices (cGMP) production areas where analytical instruments are deployed.
• Manage new instrument projects to ensure timely and compliant installation and qualification.
• Calibrate analytical instruments for conformance to established government, commercial, and specification standards.
• Develop and execute validation protocols (Installation Qualification/Operational Qualification/Performance Qualification) for analytical instruments.
• Manage standard operating procedures (SOPs) on new and existing instruments.
• Responsible for instrument re-certification with outside standard laboratories, which includes performing incoming inspections and documentation reviews on these instruments.
• Write, revise and review SOPs.
• Participate in continuous improvement functions (Lean initiatives) teams, which increase efficiency, solve problems, generate cost savings, improve customer service activities, and improve quality.
• Perform/assist in internal assessments/investigations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
• Serve as a technical resource for process and/or product development activities.
• Participate in client and regulatory audits and respond to audit observations.
• Serve as project Subject Matter Expert (SME) on lab instruments and processes.
• Understands advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Can operate advanced laboratory equipment (HPLC, UV, Karl Fischer, pH meter, etc.).
• Has a thorough knowledge of the US and EU pharmacopeias and a working knowledge of JP pharmacopeia.
• Ensure that data integrity requirements are maintained.
• Initiates and authors Laboratory Investigation Reports.
• Performs general laboratory/personal area clean-up.
• Identifies and leads special projects that involve…