Quality Assurance Lead - Finishing; 3rd Shift

Quality Assurance Lead
- Finishing (3rd Shift)

Bloomington, Indiana, United States

Simtra Bio Pharma 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  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.

The role:

The Quality Assurance Lead –Packaging is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager. They provide direct support to 3rd Shift Quality Assurance (QA) Associates and Manufacturing
- Packaging to ensure that finished products meet the required specifications. The supervise and lead QA Associates, who provide quality oversight in the Inspection and Packaging complex. The QA Lead
- 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 support departments. The QA Lead
- Packaging creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The working hours for this position are Monday-Friday 10:45p-6:45a

The responsibilities:

• Ability to handle multiple projects and demonstrate effectiveness in team leadership, empowerment of others, task completion, decision-making and problem-solving, deviation management. A functional understanding of FDA, Quality Systems, and GXP application is also required.
• Must be able to become a Subject Matter Expert (SME) on applicable Quality procedures for Inspection and Packaging. Ensures department policy procedures align with Global and Regulatory standards.
• Plans and schedules the work of QA Inspectors for required quality inspections and label control.
• Interviews, hires, coaches, and develops staff. Provides guidance, support, direction and leadership through positive interactions with all personnel during daily operations. Conducts performance reviews for all direct reports, including setting performance objectives and development plans.
• Achieves defined quality objectives aligned with site goals in an efficient, accurate, and timely manner.
• Ensure business needs and timeliness requirements of the department are met or exceeded
• Participate in or lead 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.
• Ensure Inspection and Packaging complex is always in an audit ready state. Maintain a high level of expertise in current regulatory and client requirements.
• Assists and approves validations, audits, and assessments. Authors, reviews, and/or approves deviations, 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 batch processing.

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 in a leadership role.
• Knowledge of inspection/labeling/packaging equipment and processes is preferred
• Good interpersonal communication skills.
• Working knowledge of FDA Regulations, Application of Good Documentation Practices and Good Manufacturing Practices.
• Strong technical writing skills.
• Strong problem-solving skills.
• Computer…