Serán BioScience · 1 month ago
QC Manager, Environmental Monitoring and Microbiology
Bend, Oregon
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expSerán BioScience is a company focused on developing and manufacturing novel drug products for various pharmaceutical applications. The Quality Control Manager, EM & Microbiology will enhance and maintain the Environmental Monitoring program while ensuring compliance with regulatory standards and leading a team in a pharmaceutical manufacturing environment.
Biotechnology
No H1B
Responsibilities
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
Qualification
Required
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
Preferred
Experience and/or knowledge of process validation lifecycle approach for biological product
Benefits
Employees are awarded generous PTO accrual
Low-cost health benefits
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
Company
Serán BioScience
At Serán, Our mission is to provide optimized drug development and manufacturing services for our clients, from discovery to the clinic.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Dan Smithey, PhD
President, CEO and Founder
Company data provided by crunchbase