Microbiology Technician III- 1st Shift

About the role

We are hiring for a Microbiology Technician III supporting our 1st shift role in Operations Quality at the Santa Ana facility, supporting tissue valve manufacturing. The Technician III position will support operations through testing of various samples from the manufacturing area, which will include bioburden testing, sterility testing, and environmental monitoring. Investigating potential quality issues related to microbiology, driving continuous improvements within the lab, and more. The ideal candidate is someone with firsthand microbiology testing experience.

Responsibilities

Responsibilities may include the following and other duties may be assigned.

• Performs analysis, inspection, and tests of raw materials, production samples, and/or finished products from manufacturing, to ensure quality standards and compliance to manufacturing instructions and regulatory requirements.
• Performs a variety of tasks to aid in manufacturing issues and initial investigation activities into potential nonconformities.
• Reviews data for conformance to procedures.
• Technical writing - documents investigations into potential nonconformities and drafts nonconformance reports.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Requires 3 years of experience
• No minimum education requirement.

Qualifications

• Science based degree.
• Experience with aseptic technique, sterility testing, bioburden testing, endotoxin testing.
• Problem-solving skills – troubleshooting and root cause analysis skills for process or product excursions.
• Lean Manufacturing/Continuous Improvement experience – Exposure to methodologies like 5 whys, A3 and/or participation in Kaizen events to drive process improvements.
• Familiarity with quality standards and regulatory requirements – Understanding of ISO standards, FDA regulations, or other relevant industry quality standards.
• Technical writing skills – Ability to create technical documentation, reports, and NCMR-related records.
• Systems knowledge: SAP, Agile, Microsoft Office products especially Excel and Word.

Pay

• Salary ranges for U.S (excl. PR) locations (USD): $56,000.00 - $84,000.00
• This position is eligible for a short-term incentive called the Operations Incentive Plan (OIP).

Benefits

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)

The following benefits and additional compensation are available to all regular employees:

• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.