Job Title: Quality Assurance Supervisor

Work Location: Bergen County, New Jersey

Summary:

The Supervisor coordinates and oversees the day-to-day aspects of the QA staff, including training and development of QA staff. Monitor and maintain compliance with current regulatory requirements (cGMP, GLP, GTP, CFR, PTC and ICH) and internal SOPs. Drive continuous quality improvement through communication/training, waste reduction, and mistake-proofing. Solicit and implement industry best practices.

Responsibilities:

• Keeps team current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.)
• Audits raw data in accordance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Code of Federal Regulations (CFR) guidelines
• Monitor and maintain quality systems and procedures (SOPs) for adherence to regulatory compliance requirements. Focus on driving continuous quality improvements. Initiates and revise SOPs and Policies as necessary.
• Perform trend analysis, report results and coordinate corrective and preventative actions (CAPA) to drive compliance and quality initiatives. Measure, track and evaluate key quality metrics to support future quality initiatives and resource allocation.
• Lead and/or participate on cross-functional teams and projects representing quality in positive and compliant manner.
• Conduct documentation review and approval including but not limited to: Testing and Manufacturing Batch Records, Cleaning Record, Client Protocols, Training Records, Qualification/Validation Documents
• Review, approve and perform investigations, as needed, and provide guidance for CAPA related to non-compliance situations using creative problem-solving skills.
• Supports QA aspects of the change control processes (equipment, facilities, utilities and document) and ensure are handled in a compliant manner.
• Supports and actively participates, as needed, in client and regulatory audits/inspections.
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Plans, monitors, and appraises direct reports including performance competencies, goals & job results.
• Coaches, counsels, and conducts disciplinary actions
• Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.
• Ability to work in a team environment and independently as required
• Contributes to the overall operations and to the achievement of departmental goals
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Other duties as assigned
• May be required to assist in other departments

Leadership Responsibility:

• Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies.
• Identifies, recruits, and retains top-notch talent.
• Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.
• Develop employees to meet both their career and organizational goals.
• Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
• Comfortable working in ambiguous situations and adaptable to change.
• Must model the highest degree of moral and ethical behavior and maintain confidential information.
• High degree of autonomy and strong decision-making skills.

Qualifications:

• HS Diploma or equivalent required and 5+ years relevant technical experience and minimum 2 years in a Lead/Leadership/Supervisory Role
• BS/BA in science related field preferred; or combination of relevant experience and education
• Diploma is acceptable, but BS with 5+ years of QA experience and 2+ years supervision experience preferred
• Pharma experience in QA required
• Extensive experience writing and/or reviewing/approving Deviations and Low-risk non-conforming events (NCE) Laboratory Investigations / Deviations / CAPA’s preferable
• Sound knowledge and interpretation of FDA and EU cGMP requirements
• Works on moderately complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
• Having wide-ranging experience, use professional concepts and objectives to resolve moderately complex issues in creative and effective ways
• Ability to accomplish the duties described using appropriate computer equipment and software (Microsoft Word, Excel, and Access)
• Ability to record data accurately and legibly
• Very good oral and written communication skills
• Ability to work effectively as part of a team and to exhibit effective interpersonal skills
• Flexible in managing deliverables and working hours to meet business objectives
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication
• Will lead a team of 3-5 specialists
• 50% on the floor, and 50% behind the computer doing QMS work

Published Category: Quality & Validation