0197 Analyst, QC I

DUTIES:
The QC In-Process (QCP) Technician is responsible for supporting microbiological and analytical data management within Current Good Manufacturing Practices (cGMP) guidelines, in support of manufacturing commercial and clinical operations.

CHARACTERISTICS:
Functional activities may include but not limited to maintaining test sample throughput and data management (data entry, test record reconciliation/archival, etc.).
Employee is expected to follow Standard Operating Procedures (SOPs), follow instructions in daily activities, and be able to recognize deviations from routine practices.
Incumbent must accurately complete tasks on time to achieve lab goals, meanwhile limiting GMP / procedural errors, and be capable of accepting and incorporating feedback.
Must also demonstrate the ability to both manage time and prioritize routine work effectively.
Communication of relevant information must be made to appropriate audiences, and attendance of necessary team meetings with some participation in discussions is essential.
Employee must demonstrate good documentation skills.
Employee should also be actively engaged, motivated, and organized in his/her role.
Incumbent must exhibit frequent volunteerism as the work schedule flow permits and maintain a positive attitude.

RESPONSIBILITIES:
Assist in data entry of product samples using enterprise systems such as Labware LIMS, etc.
Assist in test record generation, management, and archiving.
Assist in test record retrieval in support of Laboratory Investigation Reports (LIR) and/or Deviations.
Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures.
Attend team huddles and department meetings.
May interact with other departments including, but not limited to, Manufacturing, Validation, Product Development, and Analytical Chemistry.
Perform other responsibilities as deemed necessary.

QUALIFICATIONS:
Associate in Science degree or high school diploma with 2 years general work experience.
0-2 years of relevant laboratory experience; QC specific experience is preferred.
Familiar with quality management systems, current Good Manufacturing Practices, and QC principles.
Must demonstrate close attention to detail.
Demonstrate working knowledge with respect to trained functional activities.
Good documentation, written and verbal communication skills are essential.
Must possess the ability to perform most tasks under supervision.
Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.
Must have a quality service attitude and focus.

PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.