Quality Associate I - Filling (weekend second shift)

Simtra BioPharma Solutions is seeking a Quality Associate I to join their Quality Assurance Line Operations Team. This role involves maintaining quality oversight of manufacturing areas, working closely with manufacturing personnel, and performing checks during manufacturing processes. The Quality Associate I also assesses regulatory and quality risks, contributes to continuous improvement, and supports a work environment focused on teamwork, productivity, and product quality. This position supports Weekend 2nd Shift.

Responsibilities:

• Ensures compliance with regulatory requirements and company regulations.
• Reviews batch records and other documents for completeness and accuracy.
• Reports errors and discrepancies to management and provides direction.
• Performs quality functions in classified areas, including production oversight.
• Prepares for internal and external audits.
• Initiates and authors nonconformance reports (NCRs) and CAPAs.
• Conducts bi-annual inspections of classified areas.
• Initiates standard operating procedure (SOP) revisions.

Requirements:

• BS degree (preferred science discipline), or AS degree with at least 1 year of Pharmaceutical Quality/Manufacturing experience, or no degree with at least 2 years Pharmaceutical Quality/Manufacturing experience.
• Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP) required.
• Intermediate (or higher) proficiency in MS Office Suite (Word, Excel, and Outlook).
• Ability to use and understand enterprise software (i.e., JDE).

Simtra offers:

• Day One Benefits including Medical & Dental Coverage.
• Flexible Spending Accounts.
• 401(k) Retirement Savings Plan with Company Match.
• Time Off Program including Paid Holidays and Paid Time Off.
• Adoption Reimbursement Program and Education Assistance Program.