Quality Analyst I Quality Batch Review

Job Description

Simtra BioPharma Solutions is seeking a Quality Analyst I to join their Quality Assurance Team. The Quality Analyst I will report to the Quality Supervisor, Batch Review, and will be responsible for reviewing all quality documentation generated during filling operations and effectively communicating with customer support departments. Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.

• Performs batch record review for GMP batches produced at Simtra for accuracy and compliance to procedures.
• Reconciles discrepancies with documentation and/or electronic systems.
• Facilitates partnership and communication between Quality Assurance, Production, and other support functions.
• Initiates nonconformance investigation reports.
• Participates in continuous improvement projects.
• Performs final batch record review and product release.

• Bachelor's degree required.
• Experience in Pharmaceutical Quality or Manufacturing preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook.
• Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, etc.).

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child 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
• Vision Coverage
• Accident Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal and more
• Workout Facility
• Cafeteria
• Credit Union