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Work Schedule

Standard (Mon-Fri)

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

Title: Quality Control Investigations and Compliance Specialist

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. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Division/Site Specific Information

Position is based Manati, Puerto Rico. Position will support our Drug Product Division (DPD) at Thermo Fisher Scientific.

Discover Impactful Work:

Join Us as a Quality Control Investigations and Compliance Specialist - Lead Innovation and Excellence in Quality Assurance.

The Quality Control Investigations and Compliance Specialist ensures high standards of quality and compliance in our manufacturing plant's laboratory operations. This role primarily focuses on performing laboratory investigations and maintaining compliance against compendial requirements. The position requires expertise in regulatory compliance, laboratory operations, and technical leadership, with an emphasis on conducting thorough investigations and ensuring adherence to pharmacopeial standards.

A Day in the Life:

+ Lead and conduct comprehensive laboratory investigations, including root cause analysis, CAPA development, and implementation of corrective measures.

+ Monitor and evaluate changes in USP, EP, and other relevant pharmacopeias, assessing their impact on laboratory operations and product quality.

+ Develop and maintain systems to track and implement compendial changes effectively across laboratory documentation, methods, and systems.

+ Ensure compliance with GMP and Pharmacopeial requirements in all laboratory operations.

+ Lead the change control process for compliance-related changes, ensuring proper evaluation, documentation, and implementation of modifications to comply with updated compendial requirements.

+ Collaborate with cross-functional teams to assess the impact of pharmacopeia changes on existing products and processes and develop strategies for compliance.

+ Develop and revise key laboratory SOPs, test methods, and quality control documentation as needed to maintain compliance with compendial requirements.

+ Mentor junior staff on proper investigation techniques and compliance maintenance.

+ Represent the laboratory in high-level meetings related to compliance and investigations.

+ Develop and maintain technical writing standards for laboratory documentation, including investigation reports, SOPs, and technical protocols.

Keys to Success:

Education

+ Bachelor's degree in chemistry, biochemistry, or related scientific field is required.

Experience

+ Minimum 5 years experience in a GMP-regulated laboratory environment (3+ years in compliance, quality assurance, or quality control laboratory).

+ Experience in change control processes and pharmacopeia implementation.

Knowledge, Skills, Abilities

+ Extensive knowledge of FDA, EMA, ICH, and global regulatory guidelines

+ Expertise in USP, EP, and other relevant pharmacopeias.

+ Expertise in quality control laboratory operations, analytical methods, and instrumentation.

+ Strong systematic laboratory investigational skills including root cause analysis and CAPA development.

+ Strong project management and leadership skills.

+ Advanced knowledge of statistical analysis and risk management in GMP environments.

+ Excellent communication and technical writing skills.

+ Proficiency in Sample Manager, Empower, Trackwise, and other quality management software.

+ Ability to interpret and apply complex regulatory guidelines.

+ Strong problem-solving and negotiation skills.

Working Conditions:

+ Primary work in laboratory and office environments

+ May require travel for audits and inspections

+ Must follow safety protocols and wear appropriate PPE

+ Occasional weekend or off-hours availability for critical issues

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.