Expert - QA Technical Operations

ProBio; Pennington (NJ); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Paid time off

Flexible spending accounts

Health savings account

Life insurance

AD&D insurance

Disability coverage

Legal assistance

Pet insurance

Commuter benefits

Well-being programs

Peer recognition

Job summary

ProBio, a GenScript subsidiary, is a global CDMO offering discovery to GMP services for plasmids, antibodies, and cell & gene therapies. The role leads QA technical operations to ensure compliance with QA standards and supplier quality controls, collaborating with Facilities, Manufacturing, QC, and Validation teams.

The successful candidate will author SOPs, manage GMP supplier qualification, audits, CAPAs, and supplier scorecards while driving continuous improvement and cost of quality, in

Qualifications

• Bachelor’s degree in science, engineering, business, management or related field.
• 3-5+ 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
• Complete the approval requirements to qualify new suppliers including negotiating quality agreements, as well as audit scheduling, conduction of audits, and authoring of audit reports
• Periodic review of suppliers and identification of supplier compliance issues
• 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 CAPAs, 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
• Works closely with Facilities, QA Validation, Manufacturing, and QC teams

Skills

Interpersonal skills

Communication

Negotiation skills

Team collaboration

Problem solving

Attention to detail

Results oriented

Education

Bachelor’s degree in science/engineering/business/management or related field

Advanced degree a plus

Job description

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 Expert 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 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

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, as well as audit scheduling, conduction of audits, and authoring of audit reports
• Periodic review of suppliers and identification of supplier compliance issues
• 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 CAPAs, 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
• Works closely with Facilities, QA Validation, Manufacturing, and QC teams

Qualifications

• Bachelor's degree in science, Engineering, Business, Management or related field (Advance degree a plus)
• 3-5+ 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 $70,000 - $95,000 based on qualifications and experience.

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.

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.

ProBio Inc. maintains a drug-free workplace.