Quality Control Scientist I/II, Environmental Monitoring/Microbiology

United States·BendFull-time Exemptmid

OtherQuality Control

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Overview

The Quality Control Scientist, EM & Microbiology will be responsible for maintaining the EM/Micro program at Serán BioScience.

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OtherQuality Control

The Quality Control Scientist, EM & Microbiology will be responsible for maintaining the EM/Micro program at Serán BioScience. This role supports manufacturing through performing routine monitoring testing, utility testing, and cleaning process verifications testing. Work performed must be in accordance with US-FDA, EU and other applicable regulations. Preference will be given to those with regulatory knowledge and experience in a pharmaceutical manufacturing environment. Those with a background in microbiology and environmental monitoring in an adjacent industry 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.

Conducts routine environmental monitoring sampling and testing including viable air, viable surface, and non-viable particulate testing in non-sterile and aseptic processing environments

Conducts quality control testing of utilities including high purity water systems (TOC, Conductivity, Endotoxin, and Bioburden) and compressed gas systems (hydrocarbon, moisture, bioburden, non-viable particulates, et cetera)

Conducts growth promotion testing and qualification testing to support environmental monitoring strategy

Collects equipment swab samples in the manufacturing environment to support cleaning process verification testing

Trends environmental monitoring data and writes environmental monitoring trend reports

Writes microbiological testing protocols and conducts microbiological testing to support manufacturing qualification activities

Authors Incident Reports, laboratory investigations, Change Controls, and CAPAs

May represent EM/Micro as an SME in support of cross-functional initiatives

Maintains laboratory cleanliness and organization through routine disinfection of laboratory surfaces and equipment, inventory management, and participation in 5S activities

Coordinates with members of other departments to schedule sampling events and ensures timely communication of test results

Logs samples and standards into the QC Laboratory

Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies

Identifies opportunities for improvement and takes initiative to lead improvement efforts

Adjusts work schedule when necessary to meet testing needs

Performs other related duties as assigned

Responsibilities may increase in scope to align with company initiatives

Strong verbal and written communication skills

Strong analytical and problem-solving skills

Demonstrated ability to collaborate and work in cross-functional teams

Excellent organizational skills and attention to detail

Strong time management skills with a proven ability to meet deadlines

Ability to prioritize tasks and to facilitate delegation of tasks when appropriate

Ability to function well in a high-paced and dynamic environment

Accepts feedback from a variety of sources and constructively manages conflict

Proficient with Microsoft Office Suite or related software

Bachelor’s degree in scientific discipline. Degree in microbiology preferred.

Scientist I requires 1 year performing environmental monitoring testing and/or microbiological testing in a manufacturing environment.

Scientist II requires 2 years of GMP experience, 3-5 years preferred performing environmental monitoring testing and/or microbiological testing.

Prolonged periods of sitting or standing while monitoring equipment, analyzing data, or working on a computer

Must be able to lift up to 25 pounds regularly

Must be able to wear a Tyvek suit with PAPR for extended periods of time

Exposure to constant low-level equipment noise, and occasional high-level alarms

Work near heat generating equipment

Move up and down ladders, kneel, squat, balance on one foot

Adheres to consistent and predictable in-person attendance

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:

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.

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