Quality Supervisor - Filling (weekend PM)

Simtra US LLC; Bloomington (IN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Plan with Company Match

Paid Holidays

Paid Time Off

Parental Leave

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Vision Coverage

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, ensure finished products meet specs, and support manufacturing with regulatory compliance on the production floor.

Reporting to the Quality Manager, you will drive daily QA operations, lead investigations, and guide cross-functional teams to sustain high-quality outcomes and patient safety. Weekend/evening shifts and OT may be required.

Qualifications

• Bachelor's degree (preferred science discipline) with 2+ years in Pharmaceutical Quality/Manufacturing or 3+ years with an Associate's degree, or 5+ years without a degree in GXP.
• Minimum 2 years of leadership experience.
• Working knowledge of FDA CFR 210,211 and GDP required.
• Knowledge of aseptic manufacturing processes is required.
• Strong interpersonal/communication/influencing/negotiation skills.
• Proficient in Microsoft Word, Excel, and Outlook; able to use enterprise software (e.g., D365, Veeva).
• Strong technical, analytical, and problem-solving skills.

Responsibilities

• Perform primary responsibilities of QALO personnel.
• Grow and manage QALO personnel including hiring and evaluating performance.
• Provide rapid, quality-first decision-making with manufacturing and cross-functional teams.
• Ensure training and compliance of QALO associates and QA Technicians.
• Author and approve investigation/deviation reports.
• Lead ongoing QALO activities and assist cross-functional areas for successful execution.
• Ensure tasks are completed to meet quality and site metrics.
• Draft, revise, and review SOPs, batch records, and docs to meet regulatory requirements while supporting CI initiatives.
• Ensure compliance with all regulations related to quality and employee safety.
• Lead multiple process/product improvement projects and data generation.
• Maintain audit-ready status and understand regulatory/SOP requirements.

Skills

Leadership

Quality systems

GXP regulations

GDP

CFR 210/211

Problem-solving

Communication

Education

Bachelor's degree in science

Tools

Microsoft Word

Excel

Outlook

D365

Veeva

Job description

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.

The role:

The Quality Supervisor is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager. They provide direct support to Quality Operations (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 QALO Associate III 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 QALO Associate III creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The working hours for this role are Friday (evening) - Monday (morning) 1900 - 0700

The responsibilities:

• Able to successfully perform all the primary responsibilities of QALO personnel.
• Effectively grows, manages, develops and empowers QALO 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 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.

Required 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.
• Knowledge of aseptic manufacturing processes are required.
• Good interpersonal/communication/influencing/negation skills.
• 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

• 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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