QC Manager, Environmental Monitoring and Microbiology

Serán BioScience-posted 17 days ago
Full-time • Mid Level
Onsite • Bend, OR
251-500 employees
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The Quality Control Manager, EM & Microbiology will be responsible for improving, developing, executing, and maintaining the EM program at Serán BioScience. A large responsibility of this role will be ensuring that all aspects of the program are effectively established, implemented, and maintained in accordance with US-FDA, EU and other applicable regulations. Regulatory knowledge and experience in a pharmaceutical manufacturing environment is an essential requirement of the job. Those with GMP leadership experience with a desire to build programs, systems, and teams are encouraged to apply. Serán BioScience develops and manufactures novel drug products for a variety of pharmaceutical applications. We aim to build a workforce that is collaborative, creative, and kind. In addition to the skills required of the role, qualified candidates will approach their work with integrity and enthusiasm to promote a positive work culture. Employees are awarded generous PTO accrual, low-cost health benefits, and a 5% 401(k) contribution that does not require an employee match or vesting. Want to learn more about what we do, who we are, and how you can contribute? We look forward to seeing your application.

  • Ensures that EM & Microbiology Systems and practices are developed and implemented in accordance with the requirements of GMP
  • Represents the site in client interactions for all questions related to Microbiology testing or the Environmental Monitoring program
  • Represents the site in audits and inspections related to Microbiology testing or Environmental Monitoring program
  • Oversees daily workflow of the department and direct reports to ensure deadlines and metrics are achieved
  • Supervises Microbiology assay and EM teams, acting as an advisor to team members when determining how to meet schedules or resolve technical problems
  • Review testing and laboratory records for accuracy and compliance with cGMP and company policies and procedures
  • Develops site Environmental and Utility monitoring programs and policies, ensuring sampling plans are up to date and executed on schedule
  • Host monthly trend meetings, sharing trend information with the site Quality Council, and identifying and escalating adverse trends
  • Drives corrective and preventative actions, ensuring work is complete and the site remains in a state of control and compliance
  • Leads environmental excursion investigations
  • Monitors EM & Microbiology resource capacity and provides feedback to QC management, program management, and production planners when capacity constraints exist
  • Responsible for building and improving quality systems
  • Controls and executes deviations
  • Oversees Corrective/Preventive Action (CAPA) plans
  • Monitors and reports Out-of-Specification/Out-of-Trend (OOS/OOT) results
  • Keep management apprised of EM/Micro activities and provide input and recommendations as appropriate
  • Preparation and support for internal audits
  • Responsibilities may increase in scope to align with company initiatives
  • Performs other related duties and assigned
  • Comprehensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization
  • Proven experience developing budgets, monitoring, and escalating variances
  • Excellent knowledge of FDA/EU/ICH/CDN/AUS guidelines and inspections
  • Understanding of aseptic processing, environmental/utility monitoring, clean room qualification, and microbiological testing required
  • Maintain current knowledge of new technologies and potential applications
  • Practical knowledge and understanding of implementing phase appropriate procedures and processes
  • Excellent verbal and written communication skills
  • Excellent organizational skills and attention to detail
  • Accepts feedback from a variety of sources and constructively manages conflict
  • Excellent time management skills with a proven ability to meet deadlines
  • Strong analytical and problem-solving skills
  • Demonstrate integrity towards testing and reporting
  • Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the company
  • Strong supervisory and leadership skills
  • Ability to prioritize tasks and to delegate them when appropriate
  • Ability to function well in a high-paced and at times stressful environment
  • Proficient with Microsoft Office Suite or related software
  • BS in related scientific field, or equivalent work experience
  • Thorough knowledge of GMP, SOPs and quality control processes
  • Minimum of 3 years of experience in a lead or supervisory position
  • Minimum of 8 years of Quality Control/GMP/EM/Microbiology experience
  • Prolonged periods of sitting or standing at a desk and working on a computer
  • Prolonged periods of sitting or standing in laboratory environment
  • Must be able to lift up to 15 pounds at times
  • Motor skills required for basic laboratory operations (pouring liquids, using utensils to transfer powders, visual assessments)
  • Adheres to predicable and consistent in-person attendance
  • Experience and/or knowledge of process validation lifecycle approach for biological product is preferred
  • Employees are awarded generous PTO accrual, low-cost health benefits, and a 5% 401(k) contribution that does not require an employee match or vesting.
  • Serán employees accrue over four weeks of paid time off annually.
  • Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period.
  • Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions.
  • Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage.
  • An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
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