SUMMARY:
The
Senior QA Inspector ensures the quality of raw materials and printed packaging materials through sampling according to established procedures. This role involves collaborating with warehouse and procurement teams, facilitating the transfer of samples to Chemistry and Microbiology, managing raw material retention storage and maintenance, and reporting defects to management. The inspector is responsible for compliance with cleanroom techniques and for maintaining accurate documentation in accordance with cGMP standards. Additionally, the inspector will participate in weekend coverage and assist QA Analysts as needed.
RESPONSIBILITIES:
- Sampling Execution:
- Execute sampling of raw materials and printed packaging materials according to SOPs.
- Verify documentation before sampling initiation.
- Conduct sampling and send collected samples to Chemistry and Microbiology teams for analysis.
- Material Management:
- Manage raw material retention storage and maintenance.
- Maintain proper chain of custody for all samples.
- Report any defects or concerns related to materials immediately to the QA Supervisor/Manager and warehouse team.
- Compliance and Documentation:
- Ensure all sampling activities comply with cGMP regulations.
- Accurately document sampling procedures and results per departmental SOPs.
- Assist in maintaining quality records for audits and inspections.
- Follow cleanroom techniques to maintain a contamination-free environment during sampling and inspection processes.
- Support QA Analyst Responsibilities:
- Provide assistance to QA Analysts as needed based on operational requirements.
- Participate in continuous improvement initiatives within the QA department.
- Physical Demands:
- Ability to walk throughout the facility for approximately 85% of the shift.
- Perform manual dexterity tasks, including manipulating syringes and handling containers.
- Lift and move materials up to 50 lbs, including 55-gallon drums, and operate a pallet jack for heavier items.
NOTE: Additional tasks as directed by the supervisor or designee, as needed.
Qualifications
- Minimum: Associate’s degree in science or equivalent with 2-3 years applicable laboratory, pharmaceutical manufacturing, or related experience (QA preferred)
- Preferred: Bachelor’s degree in science or equivalent with 1-2 years applicable laboratory, pharmaceutical manufacturing, or related experience (QA preferred)
Experience
- Minimum: 1-3- year applicable laboratory or pharmaceutical production experience (QA preferred).
- Preferred: Knowledge or experience in incoming material sampling or cleanroom operations in the pharmaceutical industry
Skills
- Proficient mathematical skills for data analysis and documentation.
- Familiarity with cGMPs, EU regulations, CFR, and USP standards.
- Strong attention to detail and accuracy in documentation and sampling.
- Good organizational skills and ability to multitask effectively.
- Strong communication skills to collaborate with cross-functional teams.
- Technical Proficiency: Ability to navigate and utilize computer systems for data input and reference.
- Judgment and Analytical Skills: Sound judgment and analytical abilities to assess risks associated with incoming materials.
- Vision Requirements: Must meet vision requirements established for the position
