Quality Supervisor - Filling (3rd shift)

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a Quality Supervisor for the Filling line on the 3rd shift. You will lead Environmental Monitoring, QALO and Manufacturing quality oversight, supervise QALO personnel, and ensure finished products meet specifications while upholding Simtra SOPs.

This role requires strong decision-making, training and development of staff, investigation/deviation handling, and leading audits.

Qualifications

• Experience leading QA/production teams in pharmaceutical manufacturing.
• Knowledge of cGMP, regulatory guidance and SOPs.
• Ability to author, review and approve investigations and deviation reports.
• Strong collaboration with manufacturing and cross-functional teams.”

Responsibilities

• Able to perform EM and QALO responsibilities on the floor.
• Grow, manage, and evaluate QA personnel and contractors.
• Provide rapid, quality-first decisions with manufacturing teams.
• Ensure training and regulatory compliance of QALO staff.
• Author and approve investigation/deviation reports.
• Lead daily QALO and environmental monitoring activities.
• Ensure tasks are completed to meet quality and site metrics.
• Maintain and improve SOPs and batch records with regulatory alignment.
• Ensure compliance with all regulations affecting product quality and safety.
• Lead audits readiness and support regulatory requirements.

Skills

People management

Quality Assurance

Regulatory compliance

Investigations & CAPA

Job description

Quality Supervisor - Filling (3rd shift)

Bloomington, Indiana, United States

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 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 third shift are Monday-Thursday 10p-8:30a.

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