Quality Scientist

Work Schedule

Environmental Conditions

Job Description

How will you make an impact?

As a Quality Scientist, you will have the opportunity to support a life science manufacturing facility in Detroit with specialized quality services. You will support Quality Control (QC) through testing and disposition of Peptone product used in critical Biopharmaceutical applications. You will also be responsible for the validation of existing and new laboratory analytical and physical test methods. You will make an impact by supporting various Quality Assurance (QA) activities through support of document control processing and management, releasing raw material and finished good product, conducting batch record reviews and final product verifications, and supporting quality improvement initiatives.

What you will do:

• Perform Quality Control (QC) chemical and biological testing of raw materials and peptone finished good products.
• Perform QC laboratory functions such as setting-up, operating and maintaining laboratory equipment following standard procedures and methods.
• Responsible for documentation related to Quality Control including data analysis, recording test data, interdepartmental communications, batch history review, and creating/revising/reviewing test procedures.
• Execution and ownership of laboratory test method validations by initiating protocols and final validation reports following Q2 (R1) ICH and FDA principles.
• Write or revise standard quality control operating procedures and quality system documentation as required.
• Responsible for environmental monitoring consisting of testing, trending, and reporting for production and non-production is required as applicable.
• Write technical reports or documentation such as change management records, out of Specification analyses and data trending.
• Assist in purchasing of lab supplies as required and support of subcontractors’ activities related to lab requirement.
• Support manufacturing batch record review for adherence to Good Manufacturing Practices (GMP) and site procedures and perform quality monitoring rounds on the manufacturing floor.
• Support internal and external audits and ensure compliance of the audit program with site and standards.
• Lead/Support Quality walk-throughs (Gemba) to enhance compliance.
• Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.

How you will get there:

Education: Bachelor of Science (BS) Degree in Analytical Chemistry, Chemical Engineering, or related scientific field.

Experience

• A minimum of 2-3 prior experience in a Quality Control Laboratory setting in the Pharmaceutical/Biotech/or Life Science industry.
• Experience with the release and disposition of products through the application of analytical/physical/ or microbiological methods.
• Good analytical skills, with an ability to use scientific knowledge and statistical methods to conduct laboratory OOS investigations.
• Introduces and validates new analytical and/or biological test methods through the initiation and execution of test method validation protocols and reports.
• Demonstrated validation proficiency, with knowledge of equipment qualification (IQ/OQ/PQ)
• Prior experience with the development and /validation of standard analytical methods such as HPLC, FTIR, TLC and ICP-MS is desired.
• Proven understanding of ISO 13485:2016 standards and FDA cGMP regulations (i.e 21 CFR 820, 210 and 211).
• Prior experience with batch records reviews and releases of raw material and finished good products.
• Prior experience with an electronic Quality Management system software used for processing of documentation creation and deviation management.

Knowledge, Skills, Abilities

• Knowledge of cGMP regulations and ISO guidelines.
• Familiarity with Q2 (R1) ICH principles.
• Excellent organization skills with strong attention to details.
• Good verbal and written communication skills.
• Ability to multitask efficiently to support production demand.
• Knowledge of Microsoft Office applications (Work, Excel and PowerPoint) is a must
• Knowledge of statistical methods
• The job may require standing for long periods and carrying heavy items.

Benefits:

·       Medical, Dental, & Vision benefits – Effective Day 1  

·       Paid Time Off & Holidays 

·       401K Company Match up to 6% 

·       Tuition Reimbursement – Available after 90 Days! 

·       Employee Referral Bonus 

·       Employee Discount Program 

·       Employee Recognition Program 

·       Charitable Gift Matching 

·       Company Paid Parental Leave 

·       Career Advancement Opportunities