Quality Specialist

Job Summary: We are seeking an individual to support manufacturing operations, becoming familiar with site processes, procedures, and policies aligned with cGMPs and Health Authority regulations.

Responsibilities:

• The individual will carry out various activities to support manufacturing operations, developing knowledge aligned with cGMPs and Health Authority regulations.
• The role will involve reviewing and approving qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality-related documentation.
• The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas, which also includes getting certified for Grade A/B gowning.
• The individual may perform quarantine functions and accountability reviews.
• Supports special projects as assigned.
• The role follows cGMP and routinely makes decisions using cGMP/process knowledge.
• The individual may work with customers to resolve problems and satisfy quality and production needs.
• The role follows site safety requirements.
• The individual authors, reviews, and approves data/documents such as methods, procedures, and/or protocols.
• The individual performs all work and completes assignments in a timely manner and is an active member of 1 or more teams.
• The individual tracks/reports metrics as needed. May provide training/presentations as needed.
• The individual may help with regulatory inspections.

Requirements:

• Education: Bachelor's degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience.
• Previous Experience in the pharmaceutical industry.
• Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance/Engineering role or Technical role.
• Previous experience in food or pharmaceutical environment in regulatory/inspection role.
• Previous experience in project management, process data analysis.
• Lean Six Sigma Certification.
• Previous Experience with SAP,MEDS, etc.

About Us: Katalyst HealthCares and Life Sciences is a leading organization dedicated to delivering exceptional healthcare and life sciences solutions.