Senior Quality Specialist Position Available In Lehigh, Pennsylvania

Senior Quality Specialist Yourway, the BioPharma Services Company Allentown, PA 18106

Position Overview:

The Senior Quality Specialist with knowledge in Good Manufacturing Practices (GMP), ISO 9001:2015, and Pharmaceuticals, will play a pivotal role in ensuring production and distribution activities meet compliance and quality requirements. Responsibilities include executing root-cause analysis, risk assessments, follow-up and close out of quality investigations (QI) and CAPAs, SOP development, and other quality assurance activities. Responsibilities include, but are not limited to: Lead the QA review and assessments of quality investigations (QIs); includes performing risk assessments, leading root cause analysis investigations, tracking, follow-up, close out, and reporting/trending. Review and approve Corrective and Preventative Actions (CAPA); includes tracking, follow-up, reporting/trending, and evaluating CAPA for effectiveness. Determines and develops approach to solutions for CAPAs including working with other functions to resolve open issues and improve processes/procedures. Review SOPs, logbooks, and other documentation related to daily QA activities. Perform walkthroughs GMP areas documenting observations and areas of concern.

Complete monthly QA metrics:

CAPA and QI closures, closure rate, days past due, etc. Support internal audits of cGMP operating groups as necessary to ensure compliance to cGMP, internal procedures, and policies. Write and/or review Standard Operating Procedures and related training documentation, if required. Review and approve document change controls. Execute continuous improvement projects utilizing Lean principles, as assigned. Provide periodic updates to stakeholders for deviations, GMP and system issues, and CAPAs.

Key Qualifications:

Bachelor’s degree in pharmacy, biology, chemistry, or related technical field. Advanced degrees preferred. Minimum of 4-6 years of experience in a quality role, experience in pharmaceutical industry preferred. Knowledge of 21 CFR parts 210, and 211 FDA Regulations, cGMPs, cGDPs, ISO 9001:2015, and ALCOA+ Knowledge and previous experience with quality management software is a plus. Certified quality auditor or equivalent auditor experience is a plus. Lean Six Sigma certification (Yellow or Green Belt) is a plus. Knowledge and utilization of Continuous Improvement (Value stream mapping, Process mapping, etc.) Risk Management, data integrity tools desirable. Strong analytical, problem-solving, and decision-making abilities. Excellent written and verbal communication skills.

Job Type:

Full-time Benefits:

401(k) Paid time off

Schedule:

Day shift Application Question(s): Willing to undergo a background check

Education:

Bachelor’s (Preferred)

Language:

English (Required)

Work Location:

In person