Manufacturing Specialist Lead, Visual Inspection 2nd Shift Job at Civica Rx in P

Company: Civica Rx
Location: Petersburg, VA
Employment Type: Full Time
Date Posted: 12/18/2024
Expire Date: 02/18/2025
Job Categories: Biotechnology and Pharmaceutical

Manufacturing Specialist Lead, Visual Inspection 2nd Shift
Job Description

The Manufacturing Specialist Lead, Visual Inspection, 2nd shift will play a key part in the facility start-up. Primary responsibilities will focus on supporting daily manufacturing visual inspection operations and ensuring product quality at the pharmaceutical manufacturing site. This critical position will support manufacturing production execution, visual inspection processes, equipment operation, change management, investigations, training, and development. The ideal candidate will have a consistent track record of achieving results in a precise, detail-oriented manufacturing environment.

Essential Duties and Responsibilities:

1. Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety, and other cross-functional teams to meet visual inspection and product quality requirements.
2. Provide comprehensive technical training for Visual Inspection Operators on manual inspection procedures, defect classification, and quality assessment techniques.
3. Develop and maintain Inspection Test Sets to ensure consistent and accurate product evaluation.
4. Conduct and lead detailed product defect investigations, including root cause analysis and product impact assessment.
5. Implement and manage the visual inspection defect tracking system to document and analyze inspection findings.
6. Drive the creation, revision, and management of visual inspection-related documents such as Standard Operating Procedures (SOPs) and batch records.
7. Oversee Acceptable Quality Limit (AQL) inspections with high precision and consistency.
8. Lead monthly audits and annual requalification of all personnel trained in manual visual inspection.
9. Adapt training methodologies to optimize learning outcomes for different team members.
10. Support onboarding and continuous development of visual inspection personnel.
11. Provide technical expertise in defect classification and product quality assessment.
12. Support regulatory inspections as a Subject Matter Expert (SME) for visual inspection processes.

Qualifications & Requirements:
Basic Qualifications and Capabilities:

1. A minimum of four+ years’ experience in biopharmaceutical manufacturing in a GMP environment.
2. An associate’s degree or higher in Pharmaceutical Sciences, Biology, or a related field is preferred.
3. Extensive experience in pharmaceutical visual inspection processes.
4. Correctable 20/20 vision with no color blindness.
5. Ability to work in low-light inspection environments.
6. Detail-oriented with exceptional accuracy in product defect identification and documentation.
7. Proficiency in Microsoft Office suite and electronic tracking systems.
8. Strong communication and collaboration skills, committed to maintaining the highest quality standards.
9. Ability to perform precise mathematical calculations (percentages, multiplication/division).
10. Skilled in writing comprehensive investigation reports and procedures.
11. Self-motivated, flexible, and able to work in a fast-paced, dynamic manufacturing environment.
12. Ability to stand for extended periods and perform repetitive physical tasks.

Preferred Qualifications:

1. Previous experience as an Inspection Operator or Line Coordinator.
2. Knowledge of defect kit creation and visual inspection technologies.
3. Experience with single-use components in drug product formulation.
4. Proficiency in Enterprise Resource Planning (ERP) systems.

Additional Requirements:

1. Must be able to work occasional weekend or alternative shifts.
2. Requires on-site presence with significant time on the manufacturing floor.
3. Must be able to interact effectively with packaging colleagues and front-line leaders.

Physical Demands and Work Environment:
The physical demands described here represent those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable. #J-18808-Ljbffr