Overview
Associate Director, Quality Assurance – Hybrid Jobs in West Point, PA at Merck Sharp & Dohme
Company Overview:
Nomax, Inc is a privately held and fast-growing manufacturer of pharmaceuticals, medical devices and dietary supplements located in South County St. Louis. 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. 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. Our company is expected to continue its recent track-record of robust growth.
Position Overview:
The Quality Assurance Operations Manager has the responsibility of 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
Assures that production process compliance meets internal, regulatory, and customer requirements.
Provide on-floor/hands-on operations quality support and lead QA Ops team to resolve manufacturing quality issues to meet delivery timelines and customer expectation. Proactively identify issues and implement improvement actions with the operations team.
Lead in production related deviations, investigations, and CAPAs. Cross functionally lead corrective action projects and actions to meet expected due dates.
Manage and mentor the quality assurance operations team (5-6 FTEs) across two shifts.
Perform GEMBA walks and internal audits to monitor compliance and identify areas of improvement.
Develop and maintain key performance indicators (KPIs) related to product quality compliance and process efficiency.
Actively participate in all regulatory and/or client audits including preparation and response.
Administer site Preventative Maintenance and Calibration program including data review and monitoring compliance to schedule due dates.
Participates in the review, revision, creation and final approval of Standard Operation Procedures (SOP’s).
Drive compliance through Quality Assurance and Operations organizations for Good Manufacturing Practice guidelines including but not limited to gowning, hygiene standards, materials control, labeling and line clearances.
Must be able to work within a climate-controlled production facility, must be able to lift up to 20lbs.
QUALIFICATIONS
Knowledgeable in manufacturing quality systems including AQL sampling plans, inspection levels, defect levels, risk assessments,
Knowledgeable in Six-Sigma or other continuous improvement principles and application.
Knowledgeable in pharmaceutical, medical device, food, and/or dietary supplement manufacturing and compliance.
Excellent effective written and oral communication style for both internal and external communications across department lines.
High level of critical thinking by using logic and reasoning to identify the strengths and weaknesses of alternative solutions or approaches to problems.
Strong supervisory and leadership skills to coordinate the work and activities of others to work together and accomplish tasks.
Strong Root Cause Analysis skills.
Willingness to lead, take charge, and provide suggestions and direction.
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
Referral program
Tuition reimbursement
Vision insurance
Schedule:
Day shift
Education:
Bachelor’s (Required)
Experience:
Quality: 5 years (Preferred)
Leadership: 2 years (Preferred)
Ability to Relocate:
St. Louis, MO 63123: Relocate before starting work (Required)
Work Location: In person
Title: Associate Director, Quality Assurance – Hybrid
Company: Merck Sharp & Dohme
Location: West Point, PA
