Overview
Quality Assurance Coordinator Jobs in Chino, CA at Specialty Enzymes and Probiotics
Company Overview:
Nomax is a privately held and fast-growing manufacturer of pharmaceuticals, medical devices and dietary supplements located in south St. Louis County. Founded in 1982, Nomax primarily focuses on the manufacture of oral solid dosage products and has become one of the leading manufacturers of effervescent products in the United States.
Position Overview:
The Quality Assurance Operations Manager will be responsible for overseeing and supervising the quality assurance operations team (In-process testing, facility and equipment quality oversight, Preventative Maintenance, and Batch Record review). This role is responsible for initiation, review, and follow through of production related investigations, corrective and preventative actions, and continuous improvement in coordination with the manufacturing manager.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manage and Mentor the quality assurance operations team (5-6 FTEs as direct reports) across two shifts. Team responsibilities include:
In Process Quality Checks
Manufacturing Batch Record Review
Preventative Maintenance and Calibration
Oversee of the equipment and facility cleaning and set up process
Assures that production process meets internal compliance standards as well as regulatory and customer requirements of the Quality Management System (QMS) for the food, pharmaceutical and medical device industry.
Ensure adequate contamination controls
Ensure adequate GMP Documentation of tasks
Ensures excellent safety compliance
Works daily with the Operations Management Team (Production Manager and Maintenance Manager) to perform the following:
Reduction in manufacturing downtime (including start-ups, shift transitions etc).
Coordination of production related deviations, investigations and CAPAs
Meet deadlines of customers and internal expectations of SOPs and projects
Ensure adequate and complete training for the Operations department (QA, Maintenance and Production). This includes monitoring of tracking metrics and execution of classroom training.
Manager is expected to be an active participant in future planning/ continuous improvement, coordination of current activities and troubleshooting.
Administer the site preventative maintenance/ calibration program including data review and monitoring compliance to schedule due dates.
Must be able to work within a climate-controlled production facility, must be able to lift up to 20lbs. The person in this position is expected to spend approximately 50% of time on manufacturing floor working in team environment with direct reports or the operations team.
QUALIFICATIONS:
Knowledgeable in manufacturing quality systems including AQL sampling plans, inspection levels, defect levels, risk assessments.
Knowledgeable in the pharmaceutical, medical device, food, and/or dietary supplement manufacturing and compliance.
Willingness to lead, lake charge and provide suggestions and directions including knowledge of continuous improvement principles.
Strong root cause analysis skills including developing short term and long term changes in response to root cause.
Effective written and oral communication types for both internal and external communication across department lines.
Excellent time management and project management stills to coordinate multiple properties and respond to priority shifts. (Including individual and team priorities)
Strong drive to on time delivery and ability to execute future planning and task shifting to address projects and tasks that are shifting off schedule.
EDUCATION AND/OR EXPERIENCE
Minimum Required: B.S. or B.A. in Biomanufacturing, Engineering, Quality or related field
Minimum Required: 5+ years related GMP/quality experience including direct experience mentoring teams
SYSTEMS AND TECHNOLOGY
Proficient in Microsoft Excel, Word, PowerPoint, Outlook
Basic knowledge of project planning tools and/or software
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
On-site gym
Paid parental leave
Paid time off
Parental leave
Referral program
Tuition reimbursement
Vision insurance
Schedule:
Day shift
Experience:
Quality Assurance: 5 years (Required)
Leadership: 2 years (Preferred)
Ability to Commute:
St. Louis, MO 63123 (Required)
Work Location: In person
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Title: Quality Assurance Coordinator
Company: Specialty Enzymes and Probiotics
Location: Chino, CA
