Sr. Quality Document Specialist

Job Description

Duties & Responsibilities:

• Identifies and validates molecular targets that play a key role in a particular disease process.
• Studies origin, relationship, development, anatomy, functions, and chemical processes of living organisms; this may include studies in the growth, structure, and development of bacteria and other microorganisms.
• Conducts research to determine the effects of materials such as nutrients, drugs, serums, hormones, and other substances on tissues and vital processes of living organisms.
• Analyzes materials to determine their toxic or nontoxic properties, binding and efficacy.
• Isolates or purifies analyses, and identifies hormones, minerals, proteins, and/or cultures of microorganisms to determine their biological properties.
• Examines chemical aspects of formation of antibodies and conducts research into chemistry of cells and cell division.
• May identify and produce small quantities of new drugs, pharmaceutical compounds and/or nutrients.

Differentiating Factors:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Education:

• Requires a Baccalaureate degree.
• Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Experience:

• 5+ years of experience in the medical device industry with a strong background in microbiology laboratory processes and relevant ISO, USP, and industry standards.
• Experience in a quality control focused Microbiology lab environment.
• 5+ years of experience with Bioburden, Sterility, Bacterial Endotoxin testing, and cleanroom environmental monitoring.

Knowledge & Skills:

• 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.
• Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
• Outstanding communication and interpersonal skills with the ability to work effectively with cross-functional teams and external stakeholders.
• Proficiency in Microsoft Office Suite and quality management systems (QMS).
• Strong technical writing capability.
• Solid understanding of ISO 17025 and laboratory compliance.