Quality Associate I - Filling (2nd Shift)

Job Description

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 various checks during manufacturing processes. The Quality Associate I will also assess regulatory and quality risks in activities and processes, striving for continuous improvement and contributing to a team-oriented environment.Responsibilities:

• Ensures compliance with regulatory requirements and company regulations.
• In-process review of records.
• Reports errors, deficiencies, discrepancies and observations to management.
• Performs quality functions in classified areas.
• Works in collaboration with management teams to prepare 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 as needed.
• Ensures that SOPs are current and effective.

Requirements:

• BS degree (preferred science discipline), or AS degree with at least 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 2 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry 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 BioPharma Solutions offers:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Voluntary Insurance Benefits
• Onsite Campus Amenities