Quality Control Coordinator

Job Description

Description:

A primary focus of this role is creating and modifying LIMS test plans to support QC activities while adhering to regulatory and data integrity guidelines. The LIMS Coordinator is responsible for tracking and managing laboratory inventories within the LIMS system and to perform and verify daily verification of laboratory data for accuracy and completeness, ensuring compliance with GxP standards before submission for review.

Essential Functions:

• Register samples and input relevant test results, instrument data, and laboratory information into the LIMS system as per QC procedures.
• Manage laboratory inventories, ensuring timely replenishment and accurate record-keeping within the LIMS system as well as generate and run standard reports from the LIMS system for Laboratory Resource tracking.
• Perform and verify daily verification data for accuracy and completeness before submitting it for review.
• Create, troubleshoot and modify LIMS Test, worksheets, and test plans as needed to support QC activities.
• Train new peers in LIMS operations, including sample manager and resource modules.
• Assist QC personnel with sample registration and label generation using the LIMS software
  
  
  

Additional Responsibilities:

• Performs other functions as required or assigned.
• Hands on to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests.
• Must understand and apply cGMP requirements applicable to quality control laboratory.
• Follow up on sample status and testing progress within the LIMS system.
• Participate in continuous improvement initiatives to optimize LIMS functionality and workflows.
  
  
  

Qualifications

Education:

• Associate Degree - Required
• Bachelors Degree (BA/BS) Chemistry or related field - Preferred
  
  
  

Experience:

• 1 year or more in Pharmaceutical/manutfacturing
  
  
  

Skills:

• Proficient in laboratory informatics - Intermediate
• Strong understanding of regulatory compliance (FDA, GMP). - Intermediate
• Proficiency in inventory management systems and data analysis tools. - Intermediate
• Excellent organizational, communication, and problem-solving skills. - Intermediate
  
  
  

The hourly rate for this position ranges from $22.00 to $26.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

About Us

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.