Sr. Supervisor, QA Technical operations

About GenScript
Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.
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
Roles and 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
Travel expectations: < 10%
Qualifications
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
The estimated pay range for the role is between $90,000 - $110,000 based on qualifications and experience.
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Benefits:
Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.