Sr Quality Microbiologist

Job Title: Sr Quality Microbiologist
Job Location: North Haven, CT- Onsite
Job  Duration: 12-13 Months (possibility of extension)
Shift: 1st Shift
Payrate: $50.35 - $57.55/hr. on w2

Job Summary:

• We are looking for a Microbiologist with experience in supporting medical device manufacturing.
• Experience with bioburden, sterility, bacterial endotoxin, and environmental monitoring methods is strongly preferred.
• Strong technical writing skills and experience using document control systems is required.

Responsibilities

• Responsibilities may include the following and other duties may be assigned.
• 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.

SPECIALIST CAREER STREAM

• Typically an individual contributor with responsibility in a professional discipline or specialty.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• May act as a mentor to colleagues or may direct the work of other lower level professionals.
• The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

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.

Required Knowledge and Experience

• 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.

• Requires a Baccalaureate degree.

Must Have:

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

Nice To Have

• Solid understanding of ISO 17025 and laboratory compliance

HM's Top Needs:

1. Experience with Bioburden, Sterility, Endotoxin and Environmental monitoring tests

2. Proficiency with Microsoft office suite and strong technical writing skills

3. Experience in a quality control focused Microbiology lab environment