Quality Control Analyst

2 weeks ago


Round Lake, Illinois, United States Integrated Resources, Inc ( IRI ) Full time

Position Overview:

1st Shift

Summary: This role is integral to the Manufacturing operations.

This position entails a thorough review of manufacturing documentation. The primary responsibility is to assess batch records and other GMP documents to ensure adherence to cGMP standards, company policies, and local SOPs.

Key Responsibilities:

• Facilitate the review of batch documentation for manufacturing.

• Ensure that manufacturing batch records align with specifications and are submitted to Quality in accordance with the release schedule.

• Verify that batch documentation meets GDP standards.

• Evaluate acceptability based on specifications and standard operating procedures.

• Confirm the presence of all necessary documentation before submitting the batch folder to Quality.

• Organize files to ensure documents are easily accessible and retrievable.

• Initiate and complete GME work orders.

• Draft Non-Conformance Records (NCRs) and conduct Exception Investigations.

• Prepare TCU documentation changes, including revisions, periodic reviews, and GAP assessments.

• Utilize the Maximo system to generate department preventative maintenance work orders; assign and complete as required.

• Employ SYSTECH to review and approve batch counts.

• Initiate batch folders through necessary data entry.

• Assist with GME cycle counting as necessary.

• Perform other administrative tasks as assigned.

Qualifications:

To excel in this role, candidates must demonstrate the ability to fulfill each essential duty effectively.

Required Skills and Abilities:

• Proficient in MS Office Suite.

• Familiarity with documentation systems and batch/systems documentation is preferred.

• Exceptional attention to detail.

• Ability to work independently in a dynamic environment while adhering to written procedures. Must be organized and capable of prioritizing tasks.

• Strong verbal and written communication skills across all organizational levels.

• Identify opportunities for continuous improvement.

• Willingness to adjust work hours and work overtime based on business needs.

• Capability to lift up to 30 pounds.

• No allergies to Penicillin or Cephalosporin drugs.

Education and Experience:

• An Associate's degree or a minimum of 3 years of experience in a manufacturing environment and/or quality documentation is required.



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