Sr. Supervisor, QA Technical operations

ProBio•Pennington, NJ

11h•$90,000 - $110,000•Onsite

About The Position

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017. The Sr. Supervisor of QA Technical Operations will be responsible for: Interpreting, building upon, and complying with company quality assurance standards Managing daily supplier quality activities and controls Supporting the Strategic Supplier Qualification and Management process to meet quality, delivery, and cost objectives Developing and executing strategic plans to improve supplier quality, delivery, and costs Overseeing inbound material release process Champion quality assurance procedures, tools, and techniques Oversee external audit program Hiring, training, mentoring, and managing a small team to execute tasks related to the supplier qualification and supporting programs

Requirements

Bachelor's degree in Science, Engineering, Business, Management or related field (Advance degree a plus)
4-6+ years of experience in Quality, Manufacturing, Engineering, or related field
Results oriented, driven individual
Excellent interpersonal, communication and negotiation skills
Strong organizational and problem-solving abilities
High attention to detail and accuracy
Ability to work collaboratively in a team environment

Responsibilities

Author/Review SOPs
Oversee the GMP supplier qualification program and supplier risk management
Completes the approval requirements to qualify new suppliers including negotiating quality agreements
Periodic review of suppliers, Identifies supplier compliance issues
Manages vendor complaints
Participates in or manages quality assessments of internal operations and suppliers to analyze compliance and assess risk
Liaison between Supplier and QA representatives in addressing the quality concerns from the supply chain
Monitor supplier non-conformance performance, and drive root-cause analyses, corrective actions & process improvements to reduce the Number of Defects & Cost of Quality
Ensures effective and timely investigation and closure of all CAPA’s, supplier non conformances, complaints and product issues
Development and maintenance of measurement systems for quality costs, indicators, trends and supplier rating
Collects data and compiling supplier scorecards
Manages audit schedule and executes supplier audits
Generates specifications for materials and consumables
Responsible for disposition of materials and consumables
Approve calibration reports for GMP equipment
Support QA Validation in review of SOPs
May interface with auditors during regulatory inspections
Will supervise and delegate responsibilities to a small team
Train and mentor subordinates
Works closely with Facilities, QA Validation, Manufacturing, and QC teams

Benefits

medical, dental, and vision insurance
401(k) retirement plan with a company match that vests fully on day one
paid parental leave after just three (3) months of employment
paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays
flexible spending and health savings accounts
life and AD&D insurance
short- and long-term disability coverage
legal assistance
supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
commuter benefits
well-being initiatives
peer-to-peer recognition programs