Job Description
Position Summary
The Quality Control Analyst I is an
entry-level laboratory professional responsible for performing routine quality
control testing and sampling activities in support of manufacturing operations.
This role ensures testing is completed in compliance with cGMP regulations,
standard operating procedures (SOPs), and data integrity requirements while
developing technical proficiency across laboratory methods and systems. The
analyst supports day-to-day laboratory operations, maintains accurate
documentation, and contributes to a safe and compliant work environment.
Key Responsibilities
Laboratory Testing
Perform routine laboratory testing and
sampling of environmental monitoring (EM), utilities, raw materials, in-process
samples, and finished products in accordance with SOPs and cGMP requirements.
Execute assigned laboratory testing
within established timelines while maintaining accuracy and compliance.
Utilize aseptic techniques and standard
laboratory practices throughout testing activities.
Record, review, and report laboratory
data in accordance with Good Documentation Practices (GDP) and ALCOA+
principles.
Laboratory Operations
Support daily laboratory operations,
including housekeeping, inventory management, and basic laboratory equipment
care.
Assist with sample coordination and
shipment to external testing laboratories.
Identify, document, and escalate
deviations, atypical results, and compliance concerns.
Participate in laboratory training to
develop proficiency across testing methods and assays.
Support validation, continuous
improvement, and innovation projects as assigned.
Assist with SOP revisions and laboratory
documentation updates.
Documentation & Compliance
Maintain accurate laboratory records and
raw data.
Ensure all work complies with cGMP
regulations, company policies, and quality standards.
Demonstrate commitment to data integrity
and regulatory compliance.
Laboratory Time Allocation
Approximately 80–90%
laboratory-based work.
Majority of time dedicated to routine
testing and sampling activities.
Remaining time focused on documentation,
training, and laboratory support activities.
Required Qualifications
Education
High School Diploma required.
Bachelor's Degree in a Scientific
Discipline preferred.
Experience
Entry-level experience (0–4 years) in a
laboratory environment.
Entry-level experience working within a
cGMP-regulated environment preferred.
Required Skills
Foundational laboratory skills.
Aseptic technique.
Strong attention to detail.
Understanding of data integrity
principles.
Good organizational and time management
skills.
Ability to follow written procedures and
SOPs.
Strong written and verbal communication
skills.
Basic computer proficiency, including
Microsoft Office.
Experience using SAP is preferred.
Ability to accurately maintain laboratory
documentation and records.