Quality Associate II - Filling (2nd shift)

Job Description

Simtra BioPharma Solutions is seeking a Quality Associate II 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 II will also assess regulatory and quality risks, facilitate training of new Quality Associates, and contribute to continuous improvement initiatives. This position is on 2nd shift (Monday - Friday, 2:30pm - 11:30pm).

Responsibilities:

• Facilitates training qualifications and on-going support for associates
• Leads cross functional continuous improvement project teams utilizing Lean principles
• Serves as principal quality author for significant nonconformance reports
• Provides technical support and guidance to nonconformance authors
• Acts as team leader to shift associates in absence of supervisor
• Ensures compliance with all regulations related to product quality and employee safety
• Reviews records for completeness, accuracy, and cGMP compliance
• Performs Quality functions in classified areas
• Initiates and reviews proposed SOP revisions
• Collaborates with management to prepare for audits and close audit observations

Requirements:

• BS degree (preferred science discipline) and 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or AS degree with at least 3 years of experience, or no degree with at least 5 years of 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)

The role offers:

• 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 and more
• 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
• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union