Position Summary
The Quality Assurance Specialist supports all quality-related activities under the supervision of Quality Leader, ensuring compliance with quality standards, regulatory requirements, and Good Manufacturing Practices (GMP) in a manufacturing environment. This role is responsible for monitoring production processes, conducting quality inspections, and working closely with cross-functional teams to maintain and improve product quality.
Responsibilities will include:
- Oversee manufacturing processes to ensure adherence to quality and compliance standards and meet customer requirements. This includes maintaining floor presence to interact with production staff and leadership.
- Participate and/or coordinate the corrective action process, including root cause analysis and proper closure in MasterControl.
- Perform in-process inspections and review batch records to verify conformance to specification.
- Attend GEMBA walks to observe processes, identify opportunities for improvement, and engage with frontline teams to drive operational excellence.
- Facilitate pre-and-post campaign Quality review meetings with project leaders, shift leaders and departmental staff to support preparation and identification of opportunities for improvement.
- Facilitate and/or participate in management review meetings with senior management.
- Support all quality related functions within company MRP system (SAGE) such as CoA, raw material approval, etc.
- Manage the approved supplier process and monitor performance.
- Facilitate and/or participate in weekly QC meetings with project leaders, shift leaders or department staff.
- Work collaboratively with production, engineering, and supply chain teams to resolve quality issues.
- Interface with customers on quality related issues.
- Work with appropriate leaders to ensure staff receive proper training and appropriate documentation is completed.
- Coordinate Ethics and Integrity training for all staff.
Required Experience & Knowledge
- Bachelor’s degree in (e.g., Biology, Chemistry, Engineering, or related discipline), or technical degree in related field.
- Experience Qualifications – Required(R)/Preferred(P):
- Specific Experience (Required):
- 3+ years of experience in a quality assurance role within a manufacturing environment, preferably in chemical industry, pharmaceuticals, medical devices, or food industries.
- Other Experience/Competencies (Preferred):
- Strong knowledge of GMP, ISO, and regulatory requirements
- Experience with quality systems, CAPA, root cause analysis, and auditing
- Knowledge of Quality Management Systems such as Master Control preferred
- Strong problem solving and facilitation skills.
- Ability to quickly prioritize projects & workload.
- Comfortable working in a fast-paced cross-functional team.
- Must be detail-oriented and organized, able to work both independently and as a team player.
- Effectively communicate with peers and interdepartmental colleagues
- Proficiency with Microsoft suite
Physical Demand
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to stand, walk, and climb stairs/ladders or balance.
The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
This position requires the ability to work in a variety of conditions such as an office environment, indoors/outdoors, hot/cold weather as well as the ability to work in confined spaces in a variety of environmental conditions.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
