Overview
The Quality Manager is responsible for leading the plant Quality Management System (QMS) to ensure all injection molded plastic products meet customer specifications, regulatory standards, and internal performance objectives. This role provides strategic leadership in defect prevention, customer satisfaction, audit compliance, and cost control, while maintaining fiscal accountability for quality-related budgets and cost performance.
Duties
- Applies cGMP in all areas of responsibility and ensures compliance with 21 CFR Parts 210/211, internal SOPs, and corporate quality standards.
- Provides QA operational oversight of packaging and manufacturing activities, including line clearance, reconciliation, in-process inspections, incoming inspection, and label control.
- eads and schedules Manufacturing QA staff and Incoming Quality Control staff to ensure effective coverage and compliance support.
- Guides manufacturing and supply chain Quality Record investigations (deviations, CAPA, change control), providing technical expertise to investigators and serving as the QA Operations FAM to ensure timely, thorough, and compliant execution.
- Provides Quality oversight and supports implementation of new manufacturing processes on the floor, equipment, or technologies, ensuring compliance with cGMP requirements.
- Leads QA documentation team to manage QA review of GMP documents, such as packaging batch records, to ensure completeness, accuracy, and cGMP compliance; supports batch disposition decisions in alignment with Quality Systems requirements.
- Exercises Quality authority, in collaboration with Operations and Client Services, to place product or processes on hold and stop manufacturing activities when compliance or product quality risks are identified.
- Monitors QA Operations metrics such as batch record review turnaround, Right First Time (RFT), and on-floor compliance trends; implements corrective actions to improve departmental performance and GMP execution.
- Supports regulatory inspections and client audits; ensures inspection readiness within QA Operations and partner departments.
MINIMUM QUALIFICATIONS:
- 5+ years of experience in regulated manufacturing environment.
- 3+ years of direct supervisory or leadership experience in QA manufacturing,
- Strong working knowledge of cGMP regulations and pharmaceutical Quality Systems and familiarity with data integrity principles (ALCOA+).
- Experience with deviation investigations, CAPA, change control, and documentation management.
- Demonstrated ability to make independent, risk-based quality decisions.
- Strong organizational, analytical, and leadership skills.
Schedule
Monday through Friday, 8 hours per day. Additional overtime
Other
- Bilingual Spanish is a plus
- Must be legally authorized to work in the United States now and in the future, without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
Compensation
70k-120k
Pay: $70,000.00 - $105,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
