Clash
of Jobs
Browse All Jobs
Job Description
Simtra BioPharma Solutions is seeking a Quality Associate III to join their team in Bloomington, Indiana. This role supports the Quality Assurance Leadership Team and provides quality oversight in manufacturing areas, ensuring finished products meet specifications. The Quality Associate III supervises QALO Sr. Technicians, Associates I, and Associates II, and ensures compliance with regulatory guidelines and company procedures. This position supports Weekend 3rd Shift. The work schedule is 36 hours and is considered full-time.
Responsibilities:
- Provide guidance and leadership to personnel during daily operations.
- Report errors and discrepancies to management.
- Plan and schedule the work of QALO direct reports.
- Ensure compliance with regulations and company policies.
- Track and trend quality data.
- Lead continuous improvement projects.
- Develop and maintain documentation procedures.
- Prepare for internal and external audits.
- Perform quality review of Nonconformance Reports and other documents.
- Provide technical support and guidance to NCR authors.
- Interview, hire, train, and evaluate QALO personnel.
Requirements:
- BS degree (preferred science discipline) and 2 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or Associate’s 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
- 2+ years experience in a supervisory/leadership role
- Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP)
- Knowledge of aseptic manufacturing processes preferred
- Attention to detail and ability to stay organized
- Intermediate (or higher) proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
- Ability to use Enterprise software (JDE, SAP, Maximo, TrackWise, etc.)
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
