What are the responsibilities and job description for the Quality Specialist - I position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
- The role will support the review and approval of 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.
- May perform quarantine functions and accountability reviews.
- Supports special projects as assigned.
- The role follows cGMP and routinely makes decisions using cGMP/process knowledge.
- May work with customers to resolve problems and to satisfy quality and production needs.
- Follows site safety requirements.
- Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols.
- 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.
- May help with regulatory inspections.
- Education Minimum Requirement: 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.