Quality Control Analyst in Schenectady, NY

Job Title : Scientist, Quality Control

Proposed Job Title :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,  Method Transfer 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 among others.

Responsibilities :

• List up to 10 main responsibilities for the job. Include information about the accountability and scope.
• Preparation and execution of laboratory investigation plans.
• Write technical reports according to established procedures.
• Participate in technology transfer and validation projects and provide support to laboratory training area.
• Establish and maintain statistical control charts for the Analytical Laboratory.
• Understand, implement, and maintain GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
• Propose and implement changes to improve laboratory techniques and methodology.
• Independently troubleshoot and resolve analytical techniques and instrument issues.
• Interpret experimental data for conformance with product/material specifications.
• Understand and identify laboratory technique or instrumental performance in accordance with scientific principles.
• Manage laboratory investigations in accordance with procedural requirements and implements scientific protocols to determine exception event cause and implements and ensures improvement ideas are completed to facilitate team objectives.
• Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during the design and change process. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

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 4
• years of experience in a related field. Master?s Degree in Science, Microbiology, Biology, Chemistry
• or Bio-Chemistry with 2 years of experience in a related field.
• Manages multiple priorities and comply with deadlines.
• Maintains their certifications as needed for assigned job tasks.
• Demonstrates strong science skills and logical thought process.
• Verbal and written communication skills in Spanish and English.
• Knowledge of GMP, safety regulations
• Computer literate including but not limited to Office (Excel, PowerPoint, Word).

Intake call details

Description Details

• Years of experience/education and/or certifcations required: Bachelor's Degree in Science, preferably Microbiology, Biology, Chemistry or Bio-Chemistry with 4 years of experience in laboratory or technical team related field or Master's Degree in Science, Microbiology, Biology, Chemistry or Bio-Chemistry with 2 years of experience

What are the top 3-5 skills requirements should this person have?

(Examples)

• Knowledge in technology transfer, validation projects, method development or improvements, qualification of new and existent laboratory instrumentation, Data Integrity and Laboratory Information Systems
• Experience in Laboratory Investigation Process for Microbiological and Analytical areas, including environmental, product testing and utilities failures
• knpwkedge in monitoring and data analysis.
• Utilize metrics and statistical concepts to detect process deviations and to design experiments, analyze trends, and report data.

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Demonstrated scientific writing skills and strong verbal communication skills
• Ability to multitask and work within timelines

What type of environment is this person working in?

• Group setting
• Individual Setting
• Combination of both

Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours?

• 8-9 am to 5-6 pm. OT is required as needed potentially 1 to 2 hours as required.

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