Quality Associate – Quality Events

JD132
Job Title: Quality Associate 1 – Quality Events
Department: Quality Assurance 
Reports to: Quality Assurance Supervisor
Location: Bloomington, IN (Onsite) 
Position Type: Full-time, Exempt, 40 hr/wk, 1st shift

General Description: 
The Quality Associate 1- Quality Events position is responsible for supporting and maintaining the GMP-compliant quality systems related to deviations and CAPAs (Corrective Action & Preventative Action). This role provides quality oversight of quality event lifecycle management, ensures adherence to internal procedures and regulatory requirements, and interfaces directly with internal teams, external clients, and regulatory bodies. This position plays a key role in maintaining site compliance and driving continuous improvement across operations. 

Key Responsibilities: 
 Review, assess, and approve deviations and CAPAs, ensuring alignment with regulatory expectations and 
internal SOPs. 
 Provide oversight of the deviation and CAPA programs, including tracking, trending, and periodic reporting of quality events. 
 Support cross-functional investigations by facilitating root cause analysis, assessing risk, and ensuring timely record closure. 
 Collaborate with Subject Matter Experts (SMEs) and operational teams to drive effective CAPAs and prevent recurrence of issues. 
 Interface with clients to escalate and discuss quality events, ensuring timely and professional resolution of 
concerns. 
 Provides support during internal, supplier, client, and regulatory audits by facilitating the staging and 
organization of required documentation. 
 Participate in audit response efforts and own quality records related to inspection commitments. 
 Contribute to monthly and quarterly quality metrics reporting and trending. 
 Write, review, and revise Standard Operating Procedures (SOPs) related to deviation and CAPA processes. 
 Represent QA in technical project meetings and provide quality input to cross-functional initiatives. 
 Review and approve maintenance records for GMP compliance. 
 Initiates and manages QA holds on materials and equipment to prevent unintended use pending investigation or resolution of quality events. 
 Supports the training of employees on deviation and CAPA processes, root cause analysis techniques, and  technical writing to promote consistent and compliant documentation practices. 
 Perform other duties as assigned by the Supervisor in accordance with company guidelines and Standard 
Operating Procedures and appropriate industry regulations and guidelines. 
 Comply with Singota’s quality and safety management systems including requirements for documentation,  training, system use, SOPs, processes, and procedures. 

Characteristics required include: 
 Maintains a high standard of personal integrity, discretion, and ethical behavior in handling confidential and sensitive quality matters. 
 Demonstrates strong analytical and documentation skills with the ability to identify discrepancies, assess risk, and ensure accuracy and completeness in records. 
 Applies structured problem-solving and risk-based decision-making to support effective investigations and CAPA development. 
 Communicates clearly and professionally in both written and verbal formats, with the ability to interface 
effectively with internal teams, external clients, and regulatory agencies. 
 Builds strong cross-functional relationships and works constructively with others to drive timely and compliant resolution of quality events. 
 Takes ownership of assigned tasks, follows through on commitments, and proactively manages record timelines with minimal supervision. 
 Manages multiple quality records and priorities efficiently in a fast-paced, GMP-regulated environment. 
 Quickly adjusts to shifting priorities and evolving business needs while maintaining focus on compliance and quality objectives 

Work Experience and Education Requirements and Preferences: 
1. Bachelor’s Degree or equivalent experience – Science related field preferred. 
2. Minimum of 1–3 years of experience in pharmaceutical or biotechnology industry with quality systems exposure, preferably within a Quality role. 
3. Strong technical writing skills with the ability to produce clear, concise, and GMP-compliant documentation. 
4. Direct experience working with quality systems, particularly in deviation management, CAPA, or change control. 
5. Experience drafting or editing quality records such as deviations, CAPAs, or SOPs. 
6. Experience with electronic quality management systems (e.g., TrackWise, Master Control, Veeva, etc.). 
7. Understanding of root cause analysis tools (e.g., 5 Whys, Fishbone, Fault Tree Analysis). 
8. Familiarity with 21 CFR Part 210/211, ICH Q10, EU Annex 11, and data integrity principles (ALCOA+). 
9. Knowledge of ICH Q9 risk management principles.

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 insurance
• Paid time off
• Tuition reimbursement
• 401(k)
• 401(k) matching

Singota Solutions is an Equal Opportunity Employer