Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.
The role
The Supervisor, Aseptic Operations is a member of the Operations Leadership Team and reports directly to the Manager, Aseptic Operations. They lead a team of Operations personnel engaged in manufacturing of sterile injectable drug products.
The Supervisor, Aseptic Operations provides decision making and oversight to ensure compliance to all standard operating procedures and batch records. They must communicate effectively with Operations support departments (Quality, Technical Services, Engineering & Maintenance, etc.), multiple levels of management, and other customer support departments. The Supervisor, Aseptic Operations builds an environment where partnership, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.
Its 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.
Desirable 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.)
Physical / safety requirements
Ability to stand or sit for extended periods of time
Ability to lift up to 50 pounds
Ability to push/pull heavy wheeled objects (i.e.: tanks, carts, pallet jacks, etc.)
Must be able to perform overhead work (i.e.: sanitizing walls and ceilings)
Physical coordination/flexibility to allow gowning for clean room environments
Use applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
Dexterity and physical condition to perform some level of repetitive motion tasks
Ability to wear respirator usage when product or task requires
Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)
Use of hands and fingers to manipulate office equipment is required
Must be able to gown qualify for Grade A/B areas (filling)
In return, you’ll be eligible for[1]
Day One Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Holidays
Paid Time Off
Paid Parental Leave and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Employee Ownership Plan
Additional Benefits
Short and Long-Term Disability Insurance
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union
[1] Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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