Quality Assurance Coordinator

2 weeks ago


Boca Raton, Florida, United States Net2source Full time

Position: Quality Control Coordinator

Location: Boca Raton, FL

Compensation: $18.70/hr on W2

Contract Duration: 12 Months (Potential for Extension)

Overview:

The Quality Control Coordinator plays a crucial role in the quality assurance process by managing sample reception, defining testing protocols, completing Product Evaluation forms, and facilitating laboratory submissions. This position also involves liaising with various departments to ensure timely updates on laboratory investigations and supporting supervisors in the organization of testing data.

  • Key Responsibilities:
  • Provide regular updates to departments regarding sample submissions, including release testing and stability assessments.
  • Assign testing requirements for incoming raw materials and bulk lots, coordinating with supervisors for analyst assignments.
  • Communicate with relevant personnel to address re-sampling needs and gather necessary documentation.
  • Assist in the Change Control Record Program processes as needed.
  • Generate reports on quality data trends, laboratory logs, and stability assessments.
  • Review Certificates of Analysis (COA) and QA/QC reports from suppliers.
  • Create CofAs for bulk materials based on completed testing.
  • Support investigations related to customer complaints by providing relevant testing information.
  • Coordinate the submission of samples to external laboratories and manage reporting of results.
  • Generate Purchase Orders for laboratory supplies.
  • Offer training and technical guidance to the Quality Coordinator team on testing protocols.
  • Utilize AS400, SAP, LIMS, PLM, and Veeva platforms for data management.

Qualifications:

  • 1 to 3 years of experience in chemistry, microbiology, or a related field is preferred.
  • Associate's or Bachelor's degree in Biology or a related science is advantageous.
  • Strong problem-solving skills and basic mathematical proficiency are essential.
  • Proficient in computer applications, mathematics, and basic statistics.
  • Ability to lift up to 30 pounds.
  • Familiarity with chemistry and microbiology terminology and documentation.
  • Knowledge of GMP regulations for solid dosage forms and familiarity with FDA and USP testing methodologies.

Required Skills:

  • Excellent verbal and written communication skills in English.
  • Basic mathematical skills.

Performance Expectations:

  • Maintain a positive attitude towards work responsibilities.
  • Collaborate effectively within teams.
  • Adapt to changes in work tasks and environments efficiently.
  • Continuously seek improvements in processes while upholding quality standards.
  • Demonstrate creativity and curiosity in problem-solving.

Physical Requirements:

Ability to lift approximately 40 pounds. The work environment may involve exposure to various powders, chemicals, and allergens.



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