Quality Supervisor - Filling

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental

Flexible Spending Accounts

Life and AD&D Insurance

401(k) with Company Match

Paid Holidays

Paid Time Off

Parental Leave

Adoption Reimbursement

Education Assistance

Employee Assistance Program

Community & Volunteer Program

Employee Ownership Plan

Disability Insurance

Vision Coverage

Identity Theft Protection

Legal Benefits

Onsite Amenities: Workout Facility

Onsite Amenities: Cafeteria

Onsite Amenities: Credit Union

Job summary

Simtra BioPharma Solutions is seeking a Quality Supervisor to join the Quality Assurance Leadership Team in Bloomington, IN. You will supervise QALO personnel, provide oversight for Environmental Monitoring and Manufacturing, and drive compliance with regulatory requirements while supporting continuous improvement on the production floor.

You will communicate effectively with cross-functional teams, prepare for audits, and lead process improvement initiatives.

Qualifications

• Bachelor’s degree (preferred science discipline) and 2 years of Pharmaceutical Quality/Manufacturing or other GXP experience, or Associate’s degree with 3 years, or no degree with 5 years of experience.
• Minimum of 2 years of leadership experience.
• Working knowledge of FDA CFR 210,211 and GDP.
• Experience with environmental monitoring preferred.
• Familiarity with isolator filling machines highly preferred.
• Knowledge of aseptic manufacturing processes required.
• Proficiency in Microsoft Word, Excel, and Outlook; ability to use enterprise software (D365, Blue Mountain, Veeva, etc.).
• Strong technical, analytical, and problem-solving skills.

Responsibilities

• Oversee EM, QALO, and Manufacturing areas to ensure product quality.
• Lead and develop QALO and QA personnel and manage performance.
• Collaborate with manufacturing for rapid, quality-first decision making.
• Ensure training and compliance of QA staff.
• Author and approve investigations, deviations, and SOPs.
• Maintain audit-ready status and regulatory understanding across the site.

Skills

Leadership

Regulatory knowledge

GDP knowledge

Environmental monitoring

Aseptic manufacturing

Problem-solving

FDA CFR 210/211

Isolator filling familiarity

Team collaboration

Education

Bachelor's degree in science

Associate's degree + 3 years experience

No degree + 5 years experience

Tools

Microsoft Word

Excel

Outlook

D365

Blue Mountain

Veeva

Job description

The role:

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.

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.

The Quality Supervisor is a member of the Quality Assurance Leadership Team reporting directly to the Senior Manager, Quality. They provide direct support to Environmental Monitoring, QALO and Manufacturing to ensure that finished products meet the required specifications by supervising QALO personnel, who provide quality oversight in the manufacturing areas. The Quality Supervisor 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, management, and other cross-functional departments. The Quality Supervisor creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The working hours for first shift are Monday-Thursday 6a-4:30p.

The responsibilities:

• Able to successfully perform all the primary responsibilities of EM and QALO personnel.
• Effectively grows, manages, develops and empowers personnel including hiring and evaluation of performance.
• Provides rapid, quality-first decision-making in collaboration with manufacturing and other cross-functional teams.
• Ensures training and compliance of QALO associates and Quality Technicians.
• Authors and approves investigation/deviation reports.
• Leads ongoing daily QALO and environmental monitoring activities and assist other cross-functional areas to ensure successful execution/implementation.
• Ensures tasks are completed assigned to self and QALO personnel to ensure Quality and site metrics are met.
• Author, revise, and review, written standard operating procedures (SOPs), batch records, and other documentation as needed to meet Corporate, Plant, Regulatory Requirements, etc. while supporting continuous improvement initiatives.
• Ensure compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety.
• Participate and lead multiple process/product improvement projects or other focus groups, design of experiments, validations, development of new methodologies or 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 regulatory and Simtra quality requirements. Maintain a high level of expertise in current regulatory requirements.

The qualifications:

• Bachelor’s degree (preferred science discipline) and 2 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or Associate’s degree with at least 3 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 5 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience.
• Minimum of 2 years of leadership experience.
• Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP) required.
• Experience with environmental monitoring preferred.
• Familiarity with isolator filling machines highly preferred.
• Knowledge of aseptic manufacturing processes are required.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Blue Mountain, Veeva, etc.)
• Strong technical, analytical, and problem-solving skills.

Physical / Safety Requirements:

• Must wear appropriate PPE as required for various manufacturing areas
• Must be able to gown qualify for Grade C/D areas.
• Duties may require overtime work, including off-shift hours and Holidays as required.
• Use of hands and fingers to manipulate office equipment is required.

In return, you’ll be eligible for [1] :

• 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.

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.