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Form of workJob Description
JD250
Job Title: Quality Associate 1 – Laboratory Oversight
Department: Quality Assurance
Reports to: Quality Assurance Manager
Location: Bloomington, IN (Onsite)
Position Type: Full-time, Exempt, 40 hr/wk, 1st shift
General Description:
The Quality Associate 1–Laboratory Oversight is responsible for managing the workflow of records for QC/Development
activities in accordance with company and client 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. Review and disposition Quality Control/Development Laboratory records, including but not limited to, Electronic
Lab Notebook (ELN) experiments and environmental monitoring data. Ensure records are executed in
accordance with procedures and regulatory requirements.
2. Review and issue appropriate release documentation and deliverables.
3. Collaborate with various departments to ensure record specifications are accurate and related deviations are
thoroughly investigated.
4. Initiate and review laboratory investigations, aid in the investigative process, and closeout investigations.
Perform final product impact assessments for client material.
5. Interface with clients to provide support for review and release of laboratory records related to client material or
product.
6. Author deviations, CAPAs, and change controls as needed.
7. Generate and issue controlled labeling material for manufacturing operations. Review for legibility, accuracy, and
compliance to company, client, and regulatory standards.
8. Responsible for the development and issuance of Quality operational metrics.
9. Represent Quality at various project and technical meetings.
10. Write and review Standard Operating Procedures related to Quality Systems within QC/Development.
11. Must perform other duties as assigned by the Supervisor. Responsible for notifying the Supervisor when issues
arise.
12. 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 of 1-3 years pharmaceutical experience, preferably in a Laboratory or Quality role.
3. Must possess knowledge of Good Documentation Practices (GDP).
4. Experience in an aseptic manufacturing and laboratory operations is preferred
Benefits
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Singota Solutions is an Equal Opportunity Employer
