Quality Supervisor - Finishing & Packaging (2nd Shift)

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

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.

This role:

The Quality Assurance Lead -Finishing & Packaging is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager. They provide direct support to second and third shift Quality Assurance (QA) Associates and Packaging to ensure that finished products meet the required specifications by supervising Associates who provide quality oversight in the packaging areas. The QA Lead - Finishing & Packaging provides decision making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The QA Lead - Finishing & Packaging creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The second shift hours are Monday-Friday 2:00p-10:30p.

The responsibilities:

• Ability to handle multiple projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. A functional understanding of FDA and Simtra Quality systems is also required.
• Must be a recognized by all levels of the facility as a subject matter expert in their area and be able to demonstrate leadership ability.
• Plans and schedules the work of QA inspectors for required quality inspections and label printing and release.
• Interviews, hires, coaches, and develops staff. Provides guidance, support, direction and leadership through positive interactions with all personnel during daily operations. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans.
• Manage activities of self in achieving defined quality goals in an efficient, accurate and timely manner.
• Develops and maintains inspection and Label Control documentation procedures, QA inspection instructions and department policy procedures. Ensures product compliance regulations are followed.
• Ensure business needs and timeliness requirements of the department are met or exceeded globally
• Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Partners with facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations.
• Be involved in and lead multiple process/product improvement projects or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
• Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, and Simtra quality requirements. Maintain a high level of expertise in current regulatory requirements.
• Assists and approves validations, audits and assessments. Authors, reviews, and/or approves NCRs, CAPAs, TSSs, Bills of Materials (BoMs), Finishing Specification Sheets (FSS), and Line Records.
• Manages change control activities/documentation including validation change control, work orders, holds, etc.
• Tracks and trends Quality data for review and reporting
• Works closely with Production Supervision, Engineering, and Maintenance to ensure adequacy and appropriateness of resolutions to equipment issues that arise during product processing.

Desired qualifications:

• Bachelor's degree required. In Engineering, Science or related field preferred
• 3 years experience in Quality or cGMP Manufacturing / FDA regulated environment required.
• 1-2 years of experience in auditing techniques, interpreting regulations and quality system helpful.
• 1 year of leadership required
• Knowledge of inspection/labeling/packaging equipment and processes preferred
• Good interpersonal/communication/influencing/negation skills.
• Good project management skills
• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Strong technical writing skills. Must be able to clearly document audit findings within audit reports.
• Strong technical, analytical and problem solving skills.
• Good interpersonal, communication, influencing, negotiation skills.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:JDE, Trackwise, etc.)

Physical / Safety Requirements

• Must wear appropriate PPE as required for various manufacturing areas
• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may involve walking or standing for periods of time.

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
    
    
    
    
  • Short and Long-Term Disability 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
  
  
  
  • 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 12/31/25

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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy