Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Location/Division Specific Information
BioProduction Group (BPG) - Detroit, MI Peptone Manufacturing Site.
How will you make an impact?
You will provide Quality Assurance Support to a life science manufacturing facility in Detroit, MI to drive quality goals and objectives. You will make an impact by conducting root cause analysis (RCAs) and implementing corrective/preventative (CAPAs) actions and applying validation principles.
What will you do?
Use (RCA) methods and tools to investigate process/product deviations and out of specification conditions.
Implement effective corrective and preventative actions (CAPAs) to eliminate recurrence of deviations and nonconformances.
Disposition non-conforming material (final product and raw material).
Write technical reports such investigation summary reports.
Perform statistical analysis to improve process and product performance.
Lead and generate risk assessments (product and process- FMEAs).
Perform process, product and equipment validations (i.e IQ/OQ/PQ..etc) in alignment with GMP requirements including protocol and report generation, acceptance criteria and statistical sampling plans. Conduct validation failure investigations.
Drive continuous improvements in all areas and support improvements efforts.
Perform Quality Assurance (QA) responsibilities to support manufacturing activities including support to site's QMS.
Education:
Minimum: Bachelor of Science (BS) in a scientific field
Experience:
A minimum of 5 years prior experience in Quality Engineering including validation in a pharmaceutical or Life Science position. Equivalent Quality experience can be evaluated.
Experience in conducting quality investigations and establishing corrective / preventative actions.
Knowledge of Quality tools such as FMEA, risk analysis methods, validation, sampling plans, Six Sigma and use of statistical methods.
Applied risk assessment tools and methods to disposition nonconforming product.
Experience with ISO 13485 standards and FDA cGMP regulations (i.e 21 CFR 820).
Knowledge, Skills, Abilities
Excellent verbal and written communication skills and ability to collaborate across different levels of the organization.
Excellent organization skills with strong attention to details.
Ability to multitask efficiently to support production demand.
Technical proficiency: familiarity with Microsoft Office applications (Word, Excel, and PowerPoint) is required. Proficiency in a statistics data software (Minitab, JMP...etc).
Lean Sigma Green or Black Belt or ASQ CQE a plus.
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