Quality Control Manager

This job operates on a 16 / 5 cycle shift pattern.

This job specification outlines the general responsibilities associated with the role of Manager QC Microbiology on the Amgen Manufacturing site.

This role will be responsible for managing the QC Microbiology team and owning, facilitating, and undertaking activities pertaining to Microbiology within QC and Manufacturing.

The successful candidate will focus on compliance, continuous improvement and implementing a lean culture and Right First Time (RFT) for QC Microbiology duties and testing, including release of commercial and global release testing.

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

The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard.

This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.

This role will be responsible for oversight of some analytical in-process methods and may require shift work depending on company needs.

Key Responsibilities

Supervision / Management of QC Microbiology team.

Ensure the QC Microbiology area is operated in a safe manner.

Overall responsibility for QC In process, Environmental Monitoring, Release and Stability testing and the associated test and laboratory documentation.

Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP Compliance with Standard Operating Procedures and Registered specifications.

Provide an effective and efficient QC service to operations by supervising, developing and coaching the QC team.

Ensure timely completion of Laboratory Investigation Reports and deviations through the Deviation procedures.

Issue trend reports on investigations, non-conformances and Environmental Monitoring and identify laboratory practices and procedures for further development / improvement.

Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.

Approval of SOPs, trend data, investigations, non-conformances, 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.

Knowledge, Skills and Experience

Primary knowledge, skills, competencies and relevant experience Knowledge :

Broad technical knowledge within Microbiology and expanding knowledge of related disciplinary areas.

Recognizes and understands the cross-dependencies of the role and understands the impacts on the organization.

Enhances own knowledge through understanding business trends and objectives.

Knowledge of industry and business principles.

Understands the core business process and purpose of the functional area in Amgen's commercialization process.

Developing own project management techniques.

Problem Solving :

Applies analytical skills to evaluate and interpret complex situations / problems using multiple sources of information.

Creates new procedures and processes to drive desired results.

Handles diverse scope of issues that require evaluation of a variety of factors including current business trends.

Autonomy :

Managerial / Supervisory experience with a proven record in a Supervisor / Team Lead role.

Experience leading cross-functional teams is desirable.

Work is guided by operational and project objectives.

Manages multiple assignments and processes.

Independently determines approach to project.

May be responsible for specific programs and / or projects.

Independently develops solutions that are thorough, practical, and consistent with functional objectives.

Contribution :

Contributes to work group / team by ensuring quality of tasks / services provided by self and others with a strong focus on RFT and Lean.

Provides training and guidance to others.

Extends capabilities by working closely with senior staff / experts within and outside the internal organization.

Skills :

Lead with initiatives to identify and drive improvements.

Communication skills (verbal and written) at all levels.

Strong technical writing skills for GMP documentation (e.g. investigations, procedures, change controls).

Presentation skills.

Escalate issues professionally and in a timely manner and know when to escalate.

Decision making skills – ability to make decisions independently.

Teamwork, coaching and motivating others.

Negotiation and influence skills, planning and organisation skills.

Investigation skills.

Demonstrated ability to interact with regulatory agencies.

Experience working with interdepartmental and cross-functional teams and influencing decisions.

Relevant experience :

Bachelor's degree in a Science related field is required.

6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with 2–3 years of specific Microbiology management experience desirable.

Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Some analytical experience for oversight of analytical in-process methods would be an advantage.

Possess key competencies to include planning / organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.

Proven experience of leading teams.

Note : This refined description preserves the original content and responsibilities while conforming to allowed formatting.

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