Job Description
Duties and Responsibilities:
- Responsibilities may include the following and other duties may be assigned.
- Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company’s quality program.
- Interprets and evaluates the analyses in terms of accuracy and precision compared aProductst established specifications and recommends and implements corrective action where necessary.
- Develops, validates, and implements controlled environment methods.
- Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.
- Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
- May also be involved in establishing requirements for the transfer of methodology from R&D.
Certifications:
- Certified microbiologist or Certified Industrial Sterilization Specialist.
Required Knowledge and Experience:
- Working knowledge of statistical techniques.
- Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
- May have practical knowledge of project management.
- Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Differentiating Factor:
Autonomy:
- Seasoned individual contributor.
- Works independently under limited supervision to determine and develop approach to solutions.
- Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact:
- May be responsible for entire projects or processes within job area.
- Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity:
- Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties .
- Makes improvements of processes, systems or products to enhance performance of the job area.
- Analysis provided is in depth in nature and often provides recommendations on process improvements.
Communication and Influence:
- Communicates with senior internal and external customers and vendors.
- Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
Leadership and Talent Management:
- May provide guidance, coaching and training to other employees within job area.
- May manage projects, requiring delegation of work and review of others’ work product.