Sr Associate Quality Control

Amgen Foundation, Inc.; Dún Laoghaire; Teletrabalho; EUR 65 000 - 90 000; Tempo integral

Resumo da oferta

Amgen Ireland seeks a QC Senior Associate to lead and coordinate activities in the QC Bioanalytical Sciences laboratory at the manufacturing site. The role focuses on lab operations, compliance, continuous improvement projects, and acting as a role model for colleagues, with minimal supervision.

You will drive lean initiatives, support Right First Time goals, and represent the QC unit in interactions with customers and regulatory bodies, while contributing to procedure development and validation

Qualificações

• Hold a third level qualification in biology/biotechnology or related discipline.
• Experience with regulatory inspections and interaction with inspectors is preferable.
• Experience leading cross-functional teams and influencing decisions.

Responsabilidades

• Lead and coordinate QC activities in the Bioanalytical Sciences laboratory.
• Ensure compliance with cGLP and cGMP within the QC unit.
• Participate in regulatory inspections and liaise with internal/external customers.
• Provide technical guidance, training, and problem solving to staff.

Conhecimentos

Excellent communication

Regulatory knowledge

Cross-functional leadership

Problem-solving

Team training

Formação académica

Degree in Biology/Biotechnology or related

Descrição da oferta de emprego

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Overview:

This job specification outlines the general responsibilities associated with the role of QC Senior Associate for the QC Bioanalytical Sciences laboratory on the Amgen Manufacturing site.

This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, with minimal supervision, acting as a role model for other lab colleagues.

The role undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT).

The role also represents the QC unit by liaising with internal and external customers.

Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Key Responsibilities:

• Experience in a wide variety of analytical techniques including but not limited to Cell-Based Potency Bioassays, Immunoassays, Cell Culture and Aseptic Technique. Experience with liquid-handling robots is also preferable.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Participate in the peer review of analytical data.
• Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
• Lead training of staff on technical aspects of job as required.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Qualification of analytical equipment and related testing functions.
• Participate in Analytical Method Transfers
• Compliance with Standard Operating Procedures and Registered specifications.
• Ensure the laboratory is operated in a safe manner
• Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
• Ensure timely completion of Laboratory Investigations and Deviations
• Participate in the generation and update of SOP’s, trend data, investigations, Deviations, validation protocols, reports, method validation/verifications and equipment qualifications.
• Participate in regulatory agency inspections as required.
• Plan and implement procedures and systems to maximise operating efficiency.
• Manage and contribute to the achievements of department productivity and quality goals.

Qualifications:

• Excellent written and verbal communication skills
• Knowledge of applicable Regulatory requirements
• Experience with Regulatory inspections and interaction with inspectors is preferable
• Experience leading cross-functional teams
• Experience working with teams and influencing decision
• Skilled in the use of problem-solving tools/techniques

Knowledge and Experience:

• Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
• Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory.
• Strong background in Cell-Based Potency Bioassays, Immunoassays and Cell Culture is essential.
• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.

What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer.

We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.