QC Pharma Projects Supervisor

ABBVIE; Town of Westport (WI); In loco; USD 85.000 - 110.000; Tempo pieno

Descrizione del lavoro

AbbVie is hiring a QC pharma projects supervisor for a fixed-term period of 12 months at its Westport site. The role leads a team of 8-12 in the Projects team, overseeing QC activities supporting operations cleaning validations, residual monitoring, and method transfers to QC laboratory.

The candidate should have a science degree and 3+ years in GMP/GLP analytical labs with proven team leadership, plus hands-on experience with HPLC/GC and Empower software.

Competenze

• Third-level qualification in a science discipline, preferably chemistry.
• 3+ years of experience in a GMP/GLP Analytical lab environment plus experience managing a team in the lab.
• Experience using HPLC, GC, and other laboratory techniques.
• Experience and good knowledge of Empower.
• Excellent communication, presentation, organisation, time-management and teamwork skills.

Mansioni

• Provide guidance to direct reports to ensure activities are completed on schedule in a GMP-compliant manner.
• Maintain relationships with management, colleagues, direct reports and customers across units and QA.
• Motivate the team and take corrective action on performance when required.
• Hold performance meetings in line with company policy.
• Update time management system and monitor attendance/timekeeping.
• Participate in training and certification of new employees.
• Ensure area is fully staffed and manage constraints.
• Coach and develop team members for succession planning.
• Represent the company as SME during regulatory inspections as required.
• Provide analytical support and scheduling for residual monitoring, process validations and cleaning validations.
• Lead New Product Introductions from an analytical perspective, including method co-validation and onboarding of new hires.

Conoscenze

Team leadership

GMP/GLP knowledge

Analytical skills

HPLC

GC

Empower software

Regulatory compliance

Time management

Formazione

B.S. in Chemistry or related field

Strumenti

Empower Chromatography Software

LIMS

Descrizione del lavoro

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

We are currently hiring a QC pharma Projects Supervisor for a fixed-term period of 12 months at our Westport site. The QC Pharma Projects Supervisor will lead a team of 8-12 direct staff members within the Projects team. The role is responsible for overseeing the QC Pharma Projects team in supporting Operations cleaning validations, residual monitoring and method transfers to the QC laboratory.

Responsibilities

• Provide guidance to direct reports to ensure activities are completed on schedule, in a GMP-compliant manner and in line with regulatory, Quality Assurance, Environmental Health and Safety, and corporate requirements.
• Maintain strong relationships with management, colleagues, direct reports and customers across the business units and Quality function, and communicate analytical requirements clearly, concisely and professionally.
• Motivate the team and take appropriate corrective action on individual or team performance where required.
• Hold performance meetings in accordance with company policy.
• Update the time management system and take appropriate action where attendance or timekeeping is below the expected standard.
• Actively participate in the training and certification of new employees.
• Ensure the area is fully staffed and manage any constraints appropriately.
• Coach and develop team members to support company succession planning.
• Represent the company as a subject matter expert during regulatory inspections, as required.
• Provide analytical support and scheduling for residual monitoring, process validations and cleaning validations across all business units.
• Lead New Product Introductions from an analytical perspective, including method co-validation and onboarding of new hires.

Qualifications

• Third-level qualification in a science discipline, preferably chemistry-related.
• 3+ years of experience working as an analyst in a GMP or GLP Analytical lab environment plus experience managing a team in the lab.
• Experience using a range of analytical equipment, specifically HPLC and GC, along with other laboratory techniques.
• Experience and good knowledge of Empower.
• Excellent communication, presentation, organisation, time-management and teamwork skills.
• Clear understanding of working within a regulated environment
• Strong analytical capability with a proven track record of problem-solving and troubleshooting, including assay-related issues.
• Ability to plan and schedule, make sound decisions, understand issues and opportunities, and provide viable solutions.
• Ability to build strong working relationships across the business and communicate quality requirements clearly, concisely and persuasively.
• Ability to work in a fast-paced, dynamic environment and adjust readily to unexpected constraints.
• Commitment to conducting activities on behalf of the company to a high standard of business ethics and in compliance with applicable laws and regulations.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico applicants seeking a reasonable accommodation,