Quality Associate I - Filling (weekend third 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 will also assess regulatory and quality risks in activities and processes, striving for continuous improvement and contributing to a team-oriented environment that prioritizes safety, identity, strength, purity, and quality.

Responsibilities include:

• Ensuring compliance with regulatory agency and company requirements.
• In-process review of records.
• Reporting errors and discrepancies to management.
• Performing quality functions in classified areas.
• Preparing for internal and external audits.
• Initiating and authoring nonconformance reports (NCRs) and CAPAs.
• Conducting bi-annual inspections of classified areas.
• Initiating standard operating procedure (SOP) revisions.
• Ensuring SOPs are current and effective.

Qualifications:

• 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.
• 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.