Manager, QC

Work Schedule
First Shift (Days)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Company information

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

Position summary

Our Quality Business Unit in Manati, PR is part of our PSG OSD Division that deliver a wide range of conventional and specialized oral dosage forms and release profiles that can speed up a customer's journey of bringing molecule to medicine.

The QC Manager role is responsible for provide management and leadership in developing and maintaining laboratory resources and systems to assure that products manufactured by the organization are tested per applicable methods to assure their conformance with all specification as established in the Quality Standards and Customer specifications.

What will you do?

• Apply Good Manufacturing Principles (GMP) in all areas of responsibility
• Responsible for ensuring GMP compliance and improving quality control systems
• Engage in daily oversight and mentorship of problem requests, laboratory investigations, corrective and preventive actions
• Collaborate across functions and sites, demonstrating quality and manufacturing expertise to troubleshoot problems
• Lead operational performance by identification, monitoring, and trending of quality metrics
• Develop and deliver trainings to drive staff development, performance management and team operational efficiency
• Demonstrate and drive the Thermo Fisher values - Integrity, Intensity, Involvement, and Innovation (The Four I's).
• Deals independently with Production Leaders to resolve product and material quality problems and to assure their compliance with specifications.
• Prepares periodic reports concerning laboratory activities as required,
• Participates in the development or evaluation of training programs to assure competence
• Participates in developing and coordinating projects with Operation Management and/or Quality Department for improvement of processes and/or product quality and cost.
• Recommends changes, approves specification for new or modified materials, processes, and products

Education

• Bachelor of Science from an accredited college/university in Science, Chemistry,

Experience, Knowledge, Skills

• Minimum 5+ years of relevant work experience in a Quality Control position within the Life Sciences industry supporting regulated products
• Minimum 3 years supervisory experience
• Hands-on experience in controlled GMP environments; understanding of GMP production and procedures
• Experience leading conversations with customers and auditors
• Leadership, delegation, and motivation skills to impact performance and development of individuals
• Possesses strong organizational skills to handle and prioritize multiple tasks while meeting delivery dates
• Must be a self-starter, have excellent time management and organization skills, a high degree of work quality, attention to detail, and strong interpersonal skills (written and oral)
• Proficient in Microsoft computer applications
• Proficient in compliance software to collect, prioritize and interpret data
• Ability to think strategically and work independently to troubleshoot and tackle problems efficiently