Night-Shift QA Lead - Packaging & Compliance

Simtra US LLC; Bloomington (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) Retirement Savings Plan with 公司

Job summary

Simtra BioPharma Solutions seeks a Quality Assurance Lead - Packaging to join the QA Leadership Team in Bloomington, Indiana. This role provides direct supervision of QA Associates in the Inspection and Packaging area and drives compliance with regulatory standards and Simtra SOPs on the production floor.

The position supports manufacturing operations Monday–Friday 10:45p-6:45a and requires strong FDA/GxP knowledge, leadership, and problem-solving skills to ensure product quality and timely

Qualifications

• Bachelor's degree (preferred science discipline) with 2 years of Pharmaceutical Quality/Manufacturing or 3 years with an Associate's degree, or 5 years with no degree.
• 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, Good Documentation Practices and Good Manufacturing Practices.
• Strong problem-solving skills.
• Computer proficiency in Microsoft Word, Excel, and Outlook; enterprise software experience (D365, Veeva, ROBAR).

Responsibilities

• Ability to handle multiple projects and demonstrate team leadership, empowerment of others, task completion, decision-making and problem-solving, deviation management.
• Must be able to become a Subject Matter Expert on applicable Quality procedures for Inspection and Packaging; ensure alignment 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; conducts performance reviews and sets objectives.
• Achieves defined quality objectives aligned with site goals in an efficient, accurate, and timely manner.
• Participate in or lead process/product improvement projects or other focus groups, design of experiments, validations, development of new methodologies and data generation.

Skills

QA leadership

GxP knowledge

FDA regulations

Inspection/Packaging

Quality systems

Documentation skills

Problem-solving

Communication

Education

Bachelor's degree in science

Associate's degree + 3 years experience

Tools

Microsoft Word

Excel

Outlook

D365

Veeva

ROBAR

Job description

Simtra BioPharma Solutions seeks a Quality Assurance Lead - Packaging to join the QA Leadership Team in Bloomington, Indiana. This role provides direct supervision of QA Associates in the Inspection and Packaging area and drives compliance with regulatory standards and Simtra SOPs on the production floor.

The position supports manufacturing operations Monday–Friday 10:45p-6:45a and requires strong FDA/GxP knowledge, leadership, and problem-solving skills to ensure product quality and timely