Supervisor, Environmental Monitoring bei Axogen
Axogen · Vandalia, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in Vandalia
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Why you’ll love working at Axogen:
- Friendly, open, and fun team culture that values unique perspectives
- Company-wide dedication to profoundly impacting patients’ lives
- Comprehensive, high-quality benefits package effective on date of hire
- Educational assistance available for all employees
- Matching 401(k) retirement plan
- Paid holidays, including floating holidays, to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Supervisor, Environmental Monitoring
The Environmental Monitoring (EM) Supervisor is responsible for the EM technician personnel including training, scheduling of EM collections, and coordination of instrumentation and supplies required for EM collections. Position requires partnering with Operations and Quality to ensure samples are collected as required and appropriate procedures are followed to ensure accuracy of QC testing of the samples. Position requires strong organizational skills related to scheduling the collections and maintaining staffing to support the EM program. The position will schedule collections based on a 7 day/3 shift schedule. The candidate will also perform document reviews and GMP document corrections as required.
Requirements of the Supervisor, Environmental Monitoring
- Associate or bachelor’s degree in microbiology or biology or closely related field.
- 3 years’ experience in microbiology in a regulated industry.
- Strong organizational skills and attention to detail.
- Ability to communicate across multiple departments is required.
- Prior experience in a Supervisory position supporting Operations or QC or experience with EM testing and GMP documentation.
- Understanding of aseptic and sampling techniques is also desired but not required.
- Position may require adapting to various shifts based on operational needs.
Responsibilities of the Supervisor, Environmental Monitoring
The specific duties of the Supervisor, Environmental Monitoring include but are not limited to:
- Managing the collection of viable and non-viable samples (static/dynamic) to support various steps in the batch record operation (dynamic sampling) and any other required samples.
- Managing the EM technician training on required collection techniques along with instrumentation maintenance.
- Developing and maintaining a defined collection schedule in coordination with Operations, QC, and Facilities over all shifts of the operation and in multiple ISO classified rooms/areas.
- Ensuring that proper labeling and collection of samples and proper data recording is maintained and that samples are collected and placed in QC in a manner ensuring accuracy of test results.
- Reviewing and approving data for EM protocols as required.
- Revising the collection schedules as required based on input from Operations to ensure samples are collected at the required steps in the batch production process.
- Perform investigations related to EM collection or EM data as required.
- Coordinating with QA to ensure proper samples collections are completed as part of room releases prior to production week startup.
- Coordinating cleaning and sanitation activities as required.
- Complying with all company policies, procedures, and SOPs.
- Performing all other duties as required.
Location
913 Industrial Drive Place, Vandalia, OH 45377
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Benefits/Compensation
This position is eligible for an annual bonus.
Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
