Quality Control Manager, Environmental Monitoring and Microbiology

Quality Control Manager, Environmental Monitoring and Microbiology

The Quality Control Manager, EM & Microbiology will be responsible for improving, developing, executing, and maintaining the EM program at Sern 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.

Sern 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.

Duties and 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

Required Skills and Abilities

Education and Experience

Physical Requirement

Visit https : / / www.seranbio.com / careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary : Sern 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. Sern 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.

The Corporate Headquarters of Sern BioScience are located at 63047 Layton Ave, Bend, OR 97701

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