Quality Associate III - Filling (weekend 2nd shift)

Job Description

Simtra BioPharma Solutions is seeking a Quality Associate III to join their Quality Assurance Leadership Team. This role supports QALO and Manufacturing, ensuring finished products meet specifications by supervising QALO Technicians and Associates. The Quality Associate III provides decision making and oversight to ensure compliance with regulations and Baxter Standard Operating Procedures. This position supports Weekend 2nd Shift which includes weekends, holidays, and flexible workdays.Simtra expects that the new hire will perfom below responsibilities:

• Providing guidance and leadership to personnel.
• Reporting errors and discrepancies to management.
• Planning and scheduling work for direct reports.
• Ensuring compliance with regulations and company policies.
• Leading continuous improvement projects.
• Leading change control activities.
• Performing quality review of Nonconformance Reports and other documents.

Simtra expects from candidates to have the following qualifications:

• BS degree (preferably science discipline) or equivalent experience.
• 2+ years of experience in Pharmaceutical Quality/Manufacturing or a GXP regulated industry.
• Experience in a supervisory/leadership role.
• Knowledge of FDA CFR 210, 211 and other applicable regulations.
• Proficiency in Microsoft Office Suite.
• Ability to use Enterprise software.

Simtra BioPharma Solutions offers:

• Day One Benefits (Medical, Dental, Flexible Spending Accounts, etc.).
• 401(k) Retirement Savings Plan with Company Match.
• Time Off Program and Paid Holidays.
• Paid Parental Leave.
• Adoption Reimbursement Program.
• Education Assistance Program.
• Employee Assistance Program.
• Community and Volunteer Service Program.
• Voluntary Insurance Benefits.
• Onsite Campus Amenities (Workout Facility, Cafeteria, Credit Union).