Quality Manager

Description

ABEC is at the forefront of innovation in our industry, offering highly differentiated products and services driving exceptional growth. As we expand to meet increased demand and new opportunities, we seek talented individuals to join our team and support our continued success.

We’re in a significant growth phase, with multiple key roles open across our organization. If you’re qualified for multiple positions, we encourage you to apply for the role that aligns most with your skills and experience.

Company Background: For over 50 years, ABEC has been a leading supplier to the biopharmaceutical manufacturing industry. ABEC’s unique value is based on combining long experience with the ability to engineer, design, manufacture, commission, qualify, and service the entire bioprocess to reduce overall cost, shorten time to market, and maximize productivity. ABEC’s products include process and equipment engineering/consulting services, comprehensive site services, and stainless steel and single use bioprocess equipment, including bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilization systems.

Benefits Include

• Paid holidays and vacation time
• Medical, dental and vision insurance (benefits start day 1)
• Company paid life insurance
• Generous 401K plan (40% match)
• College tuition benefit program
• Employee Referral Program
  
  

Position Summary

The Quality Manager leads the Quality team with implementation of company-wide operations procedures and process to support the overall Quality Assurance plan. This role support Quality improvement throughout the shop floor and within the team concept. Participate as cross-functional team member within assigned goal-oriented team responsibility.

This is a full-time, onsite position located at ABEC's Springfield, MO facility

Responsibilities

• Oversee all Quality staff.
• Coach, develop and provide guidance to Quality staff.
• Ensure cross-training of all Quality staff, so that all internal and external (service/installation) needs can be met.
• Drive efficiency and productivity within the team.
• Review and evaluate site Quality staff performance.
• Support and maintain ABEC Key Initiatives and Core Values.
• Support and maintain the ABEC Quality program.
• Maintain and ensure compliance to ABEC Standard Operating Procedures (SOPs).
• Support and maintain ABEC quality practices and guidelines, including best-in-industry practices such as Good Documentation Practices (GDP).
• Participate in internal, process and mock customer audits, as directed.
• Perform vendor qualification or re-qualification audits, as directed.
• Coordinate 3rd party audits of specified sites as directed (ASME, National Board, etc.).
• Coordinate and support Customer audits of the ABEC site, as directed.
• Site liaison with Authorized Inspection (AI) Agency personnel (Vessel Manufacturing sites only).
• Coordinate team involvement in Pre-FAT, FAT, SAT, and IQ/OQ activities as required.
• Corrective Action & Preventive Action (CAPA).
• Coordinate assigned CAPA activities (Root cause analysis, short- & long-term corrective and preventive actions).
• Serve as a site CAPA mentor for assigned champions from other functions.
• Coordinate assigned Continuous Improvement initiatives, driving both cost and process improvements.
• Coordinate Quality System Change Management assignments as directed.
• Coordinate calibration activities at specified ABEC facility.
• Report to the Global Director of Quality the status and metrics of the quality program for the specific site.
• First Pass Yields (from monitored Mfg. Processes).
• Turnover Package (TOP) Audits.
• ECN Reviews.
• MRB cycle times.
• Receiving Inspections.
• Trend analysis of FAT/SAT punch list items.
• Maintain documents in ABEC archives.
• Execute other tasks as assigned.
• Ability to travel when required.
  
  

Requirements

• Bachelor’s Degree in an Engineering discipline or related Science field (ex. Chemistry, Metallurgy).
• Minimum 5 years post graduate work in a Quality or Validation fields.
• Minimum of 5 years of leadership experience in a manufacturing environment.
• Proven ability to lead, supervise and coach a team of 10 quality staff.
• Report to the Global Director of Quality the status and KPI metrics of the quality program for specific site such as First pass Yields (from monitored Mfg. Processes).
• Turnover Package (TOP)Audits, ECN Review, MRB cycle times, Receiving Inspections, Trend Analysis of FAT/SAT punch list items.
• Experience with Corrective Action and Preventive Action (CAPA) is required.
• Coordinate assigned CAPA activities (Root cause analysis, short- and long-term corrective and preventive action).
• Certifications in cGMP, ISO 9000, ASME, BPV or equivalent is required.
• Must be able to travel domestically and internationally.
  
  

Preferred Experience/Skills

• Review and evaluate site quality staff performance experience is preferred.
• Experience with Site Liaison with authorized inspection (AI) Agency personnel (Vessel Manufacturing sites only) is preferred.
• ASQ CQE, ASQ, CQM and Six Sigma would be a plus.