Quality Supervisor Filling (weekend AM)

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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 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 weekend AM are Friday Saturday and Sunday 7a-7:30p

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:

• Bachelors degree (preferred science discipline) and 2 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience or Associates 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 210211 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.
• 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 youll be eligible for1:

• 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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