The Role
Manage review, issuance, and release of batch records and protocols for manufacturing and QC/Development. Perform material dispositions, review lab records, author deviations/CAPAs/change controls, generate controlled labeling, write SOPs, produce quality metrics, support quality systems improvements, train QA staff, and interface with clients and cross-functional teams.
Summary Generated by Built In
Why join Team Singota?
We pride ourselves on a high-trust, high-accountability environment where we lift each other up. When you join Singota, you are a part of a team that respects, supports, and values its people. We celebrate wins together, brainstorm solutions together, and genuinely enjoy the work we do. The result? A team that’s not just efficient, but also passionate, dedicated, and fun to work with.
Job Title: Quality Associate 2 – Batch Release
Department: QA
Reports to: Quality Assurance Supervisor
Location: Bloomington, IN (Onsite)
Position Type: Full-time, Exempt, 40 hr/wk
General Description:
The Quality Associate 2 – Batch Release is responsible for managing the workflow of records for Manufacturing and
QC/Development activities in accordance with company, client and regulatory quality standards, including the
appropriate disposition of materials or manufactured product. This position is responsible for reviewing records for
accuracy and completeness and for identifying discrepancies or issues that could result in product impact.
1. Responsible for the issuance, review, and release of batch records and protocols. Ensure records are executed in accordance with procedures and regulatory requirements.
2. Perform disposition of materials within the electronic inventory management system, issue appropriate release documentation.
3. Collaborate with various departments to ensure record specifications are accurate and related deviations are thoroughly investigated.
4. Interface with clients to provide support for review and release of records related to client material or product.
5. Author complex deviations, CAPAs, and change controls as needed.
6. Participate in the training of new Quality Assurance staff.
7. Support continuous improvement of the site’s Quality Systems.
8. Generate and issue controlled labeling material for manufacturing operations. Review for legibility, accuracy, and compliance to company, client, and regulatory standards.
9. Review and disposition Quality Control/Development Laboratory records.
10. Write and review Standard Operating Procedures related to Quality Systems within Manufacturing and QC/Development.
11. Responsible for the development and issuance of Quality operational metrics.
12. Represent Quality Assurance at various project and technical meetings.
13. Must perform other duties as assigned by supervision. Responsible for notifying supervision when issues arise.
14. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes, and procedures
Requirements
Skills and Physical Activity Requirements:
1. Excellent internal and external communication.
2. Demonstration of positive attitude and professional presence.
3. Good time management and organizational skills.
4. Detail orientated, must be able to perform thorough reviews of documentation.
Education and Work Experience Requirements:
1. Bachelor’s degree or equivalent work experience – science related field preferred.
2. Minimum 3-5 years pharmaceutical experience, preferably in a Quality role.
3. Must possess knowledge of Good Documentation Practices (GDP).
4. Experience in an aseptic manufacturing and laboratory operations is desirable.
Benefits
- Dental insurance - effective day one of employment
- Health insurance - effective day one of employment
- Vision insurance - effective day one of employment
- Health savings account
- Life & AD&D insurance
- Short & long term disability
- Paid time off & holidays
- Employee Assistance Program
- Tuition assistance
- Sam's Club Basic membership reimbursement
- 401(k) with company match
Singota Solutions is an Equal Opportunity Employer
Skills Required
- Bachelor's degree or equivalent work experience
- Science-related field (preferred)
- Minimum 3-5 years pharmaceutical experience
- Experience in a Quality role (preferred)
- Knowledge of Good Documentation Practices (GDP)
- Experience in aseptic manufacturing and laboratory operations (desirable)
- Excellent internal and external communication skills
- Professional presence and positive attitude
- Good time management and organizational skills
- Detail-oriented with ability to perform thorough documentation reviews
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The Company
What We Do
Singota Solutions is a cGMP-compliant and FDA-registered Contract Development and Manufacturing Organization (CDMO) based in Bloomington, Indiana. The company helps clients in the pharmaceutical, animal health, and biotechnology industries accelerate drug development. They specialize in aseptic manufacturing, formulation development, supply chain management, and analytical testing, using robotic technology to produce high-quality injectable medicines in vials, syringes, and cartridges.
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