Quality Assurance Lead - Finishing (3rd Shift)

About Simtra

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 – all directly injected into patients worldwide. We hold ourselves to the highest quality and regulatory standards, emphasizing continuous improvement and cGMP manufacturing. Simtra provides support services such as 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.

Why Join Simtra?

• Make it HAPPEN – Bring a growth mindset to every opportunity, developing new skillsets and exceeding expectations.
• Make it TOGETHER – Work as one team, respecting each voice and leveraging unique strengths to solve problems innovatively.
• Make it RIGHT – Uphold high standards of excellence, fulfilling commitments to customers, patients, and team members.
• Make it COUNT – Take pride in daily work, knowing the impact on improving patient health through challenges big and small.

About the Role

The Quality Assurance Lead – Packaging is a member of the Quality Assurance Leadership Team, reporting directly to the Quality Manager. This role provides direct support to 3rd Shift Quality Assurance (QA) Associates and Manufacturing - Packaging to ensure finished products meet required specifications. The QA Lead supervises and leads QA Associates, providing quality oversight in the Inspection and Packaging complex. This position ensures compliance with all regulatory agency regulations and Simtra Standard Operating Procedures, driving quality operations on the production floor and fostering effective communication across teams. The QA Lead creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

Schedule

Monday–Friday, 10:45 PM – 6:45 AM.

Responsibilities

• Handle multiple projects, demonstrating effectiveness in team leadership, empowerment, task completion, decision-making, and problem-solving.
• Develop a functional understanding of FDA, Quality Systems, and GXP applications; become a Subject Matter Expert (SME) on applicable Quality procedures for Inspection and Packaging.
• Ensure department policy procedures align with Global and Regulatory standards.
• Plan and schedule the work of QA Inspectors for required quality inspections and label control.
• Interview, hire, coach, and develop staff; provide guidance, support, and leadership through positive interactions.
• Conduct performance reviews, including setting performance objectives and development plans.
• Achieve defined quality objectives aligned with site goals efficiently and accurately.
• Ensure business needs and timeliness requirements of the department are met or exceeded.
• Participate in or lead process/product improvement projects, validations, development of new methodologies, data generation, report development, and presentations.
• Ensure the Inspection and Packaging complex is always in an audit-ready state; maintain expertise in current regulatory and client requirements.
• Assist and approve validations, audits, and assessments; author, review, and/or approve deviations, CAPAs, TSSs, Bills of Materials (BOMs), Finishing Specification Sheets (FSS), and Line Records.
• Manage change control activities/documentation, including validation change control, work orders, and holds.
• Track and trend Quality data for review and reporting.
• Collaborate with Production Supervision, Engineering, and Maintenance to resolve equipment issues during batch processing.

Requirements

• 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 of 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 (preferred).
• Good interpersonal communication skills.
• Working knowledge of FDA Regulations, Good Documentation Practices, and Good Manufacturing Practices.
• Strong technical writing and problem-solving skills.
• Computer proficiency in Microsoft Word, Excel, and Outlook; ability to use enterprise software (e.g., D365, Veeva, ROBAR).

Physical / Safety Requirements

• Ability to perform physical tasks including bending, twisting, kneeling, and stooping.
• Ability to sit and stand for extended periods.
• Must wear appropriate personal protective equipment, as applicable.
• Duties may require overtime work, including nights, weekends, and holidays.
• Use of hands and fingers to manipulate office equipment.

Benefits

• 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, Accident, Critical Illness, Hospital Indemnity, Identity Theft Protection, Legal, and more)
• Onsite Campus Amenities:
  • Workout Facility
  • Cafeteria
  • Credit Union

Current benefit offerings are in effect through 12/31/26.