Job Title :Senior Scientist, Quality Control

Purpose :

Describes the primary goals,objective or function or outputs of this position.

• Performs laboratory testing within a GMP environment in support of one or more of the following areas; raw  materials, in-process product, finished product, stability, and/or validation. Uses scientific education and/or experiences to generate  results in accordance with GMP/procedural requirements and scientific principles. Interprets data output to determine conformance with product  specifications.
• Reviews and verifies data generated by others to determine conformance with product specifications.
• Understands  internal business process, to make appropriate prioritization of their assigned work duties.
• Has experience and command of multiple laboratory techniques to perform them with minimal error. Can train other laboratory  personnel on any technique they currently have in their training matrix.

Responsibilities :

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Understands ,implements, and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
• Proposes and implements changes to maintain procedural requirements.
• Performs analytical test methods as written to support product/material release with minimal error.
• Proposes and implements changes to improve laboratory techniques and methodology.
• Can independently troubleshoot and resolve analytical techniques and instrument issues.
• Interprets experimental data for conformance with product/material specifications.
• Understands and identifies laboratory technique or instrumental performance in accordance with scientific principles.
• Initiates appropriate exception documents in accordance with procedural requirements.
• Implements and ensures improvement ideas are completed to facilitate team objectives.
• Proposes and implements scientific protocols to determine exception event cause.

Qualifications

List required and preferred qualifications up to 10). Include education, skills and experience.

• Bachelor 's degree in Science, preferably Microbiology, Biology, Chemistry or Bio-Chemistry with 6 years of experience in related field. Master's Degree in Science, preferably Microbiology, Biology, Chemistry or Bio-Chemistry with 4 years of experience in related field.
• PhD in Science, preferably  Microbiology, Biology, Chemistry or Bio-Chemistry with 2 years of experience in related field.
• Manages multiple priorities and comply with deadlines.
• Maintains their certifications as needed for assigned job tasks.
• Demonstrates strong analytical skills and logical thought process.

Experience Level: 3-5 Years.

What are the top 3-5 skills, experience or education required for this position?

• Extensive experience and expertise in instrument and equipment qualification
• Proven experience in software qualification
• Demonstrated ability to manage change controls as the owner and conduct
• comprehensive impact assessments
• Experience conducting data integrity risk assessments
• Strong project leadership, communication, and results-driven execution skills
• Experience in software qualification
• 4 years in equipment qualification – Required

What is a nice to have (but not required) skill, experience, education, or certification?N/A

In what type of environment would this individual be working (i.e.: Team; Individual; type of office, etc.) ?

• Team work/Individual

Daily Work Schedule Expectations

• ALL Candidates must be available to work any shift
• Monday to Friday 8-5PM

Is overtime offered or required?

• Yes, must be available to work OT/DT based in business needs

Does this position offer the ability to work remotely on a regular basis or is it required to be onsite? NO

If remote opportunity exists what are the options (i.e., 1 day remote, 4 days on-site)? NO

Is Travel expected? If so, will it primarily be domestic or international? NO