Quality Associate II - Filling (3rd 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 and working closely with manufacturing personnel as well as performing checks during the manufacturing processes. The Quality Associate II will assess regulatory and quality risks, facilitate training of new Quality Associates, and strive for continuous improvement.

The position is on 3rd shift (Sunday - Thursday, 10:30pm - 7:30am).

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 (potential batch impact) reports.
• Provides technical support and guidance to nonconformance authors.
• Acts as team leader to shift associates in absence of supervisor.
• Assists supervisor in maintenance of visual controls and accountability tools.
• Ensures compliance with all federal, state, local and company-specific regulations.
• Reviews records for completeness, accuracy, and cGMP compliance.
• Reports errors, deficiencies, discrepancies, and observations to management.
• Performs Quality functions in classified areas.
• Initiates and reviews proposed standard operating procedure (SOP) revisions.
• Works in collaboration with management team to prepare for internal and external audits.

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 Pharmaceutical Quality/Manufacturing, or other GXP regulated industry experience, or no degree with at least 5 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
• 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
• 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