Description
Job Title Description:
TRUE JOB TITLE:
QC Associate (within a laboratory setting) -ENTRY LEVEL
ROLE -Working hours (1st shift; 8:00 to 4:30 with some occasional weekend and 2nd shift support). Candidate must be flexible.
POSITION SUMMARY:
Performs chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, standard operating procedures, and approved license requirements. Results are compared with specifications and documented. Incumbent has a basic knowledge of fundamental technical and quality concepts and receives daily supervision.
RESPONSIBILITIES:
Conducts Assays- Performs chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components. Learns to recognize atypical or out-of-specifications test results, instrument malfunctions and methodology problems and participates in the investigation to resolve and correct. Analyzes Results- Accountable for the accuracy and validity of testing results. Performs mathematical calculations, interprets results, records observations. May utilize Laboratory Information Management Systems. Lab Support- Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner. SOP's and Administration- Learns to analyze and interpret project/study/investigation results and findings. Learns to determine next steps under guidance of supervisor and in compliance with applicable regulations; carries out technical and administrative duties as assigned.
EDUCATION AND EXPERIENCE:
B.S. in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline. With a B.S., 2+ years of relevant Quality experience preferably in the bio/pharmaceutical industry.
TECHNICAL SKILLS:
Knowledge of regulations & procedures:
Is aware of new methodologies pertinent to the Quality function area and is able to introduce them with supervisory input.
Analytical Techniques & Methods:
has mastered most or all of the fundamental technologies, as well as some specialized technologies and relevant analytical techniques
Documentation & Systems Use:
Ability to interpret and document test results according to standard operating procedures using all standard Quality systems; strong background using LIMS
Advancing Methods:
Analyzes and interprets many project/study/investigation results. Makes limited decision on issues and informs supervisor of action taken. Contributed to design of new studies in consultation with supervisor
Prioritization:
Receives overall project direction from supervisor periodically and carries out most projects/studies/reviews/investigations without supervision. Consults with supervisor at the start and completion of new initiatives/assignments.
Teamwork: Ability to lead teams comprised of immediate group member or to work cross functionally.
SKILLS
Quality Control, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Laboratory Information Management Systems (LIMS), Reading Plates, Water Sampling/Testing
Synectics is an Equal Opportunity Employer.