Analysis Skills, Asepsis, Assays, Current Good Manufacturing Practice (cGMP), Data Quality, Detail Oriented, Documentation, Establish Priorities, High School Diploma, Housekeeping/Cleaning, Laboratory, Laboratory Operations, Operational Support, Presentation/Verbal Skills, Quality Control, Standard Operating Procedures (SOP), Testing, Time Management
The Quality Control Analyst I is an entry level laboratory role responsible for performing routine testing and sampling to support QC operations. The role focuses on developing foundational technical skills while ensuring all activities comply with cGMPs, SOPs, and data integrity principles.
Responsibilities:
Primary Responsibilities:- Perform routine testing and sampling (EM, utilities, raw materials, in process, finished goods).
- Document, review, and report data accurately per GDP and ALCOA+.
- Execute assigned testing and support activities within defined timelines.
- Support lab operations: housekeeping, inventory, basic equipment care.
- Identify and escalate deviations, atypical results, or compliance concerns.
Secondary Responsibilities:
- Assist with sample coordination and shipments to external labs.
- Support SOP revisions and documentation updates.
- Participate in training to build proficiency across assays.
- Support validation or innovation projects as assigned.
Lab Time Expectations:
- ~80 90% laboratory-based work.
- Majority of time spent performing routine testing and sampling activities.
- Limited non lab responsibilities (mainly documentation and training).
Key Competencies:
- Foundational laboratory skills and aseptic technique.
- Strong attention to detail and data integrity awareness.
- Basic prioritization and time management (with guidance).
- Clear written and verbal communication.
- Ability to follow procedures and learn new techniques.
Requirements:
- Required: High School Diploma.
- Preferred: Bachelor's Degree in a Scientific Discipline.
- Entry Level 0 to 4 years.
- Laboratory experience and basic cGMP exposure.
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Katalyst Healthcares & Life Sciences