Weekend PM Aseptic Operations Supervisor

Simtra US LLC

Bloomington (IN)

On-site

USD 75,000 - 110,000

Full time

4 days ago

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Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

Supplemental Life Insurance (Spouse/Ch

401(k) Retirement Savings Plan with 2%

Paid Holidays

Paid Time Off

Parental Leave and more

Education Assistance Program

Employee Assistance Program

Employee Ownership Plan

Disability Insurance

Vision Coverage

Accident Insurance

Identity Theft Protection

Job summary

Simtra BioPharma Solutions is seeking a Supervisor, Aseptic Operations to lead a manufacturing team on sterile injectable production. You will ensure compliance with cGMP, manage daily operations, and coordinate with Quality, Engineering and Technical Services to meet batch release timelines.

Reporting to the Manager, Aseptic Operations, you will mentor staff, oversee training, perform performance reviews, and drive continuous improvement through audits and deviations investigations, while

Qualifications

Bachelor's Degree in a science, engineering, or business discipline strongly preferred.
High School diploma or GED required.
Minimum 2 years of manufacturing or operations support experience required.
Minimum 1 year leadership experience required.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Microsoft Dynamics, Veeva, PowerBI, Trackwise, etc.).

Responsibilities

Understand, follow, coach, and lead their teams to execute production activities in accordance with current Good Manufacturing Practices (cGMP).
Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.
Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities in order to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence.
Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations.
Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operational efficiency and quality. Implement changes as needed based on assessments.
Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
Resolve technical, material and cGMP problems that may impact project deadlines.
Provide guidance and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable.
Obtain qualification to perform select critical operation processes.
Represent the company during audits and inspections.