Executing daily activities in the QC Laboratory, including the coordination and support testing for the production of company product.
Oversee and/or assist with tasks related to the activities associated with operation of Company. Quality System and as directed by Quality Management.
Support all activities related to analytical assessment of Company products and the manufacturing environment.
Advise Quality Assurance, Manufacturing and R&D departments on matters related to analytical testing and support
Perform a variety of tasks to analyze pharmaceutical compounds, inspect incoming supplies and release OEM product.
Familiarity with laboratory procedures and can reliably conduct analysis.
Perform and/or assist with tasks required to oversee the proper operation and monitoring of the manufacturing clean room facility, packaging and QC lab operations as directed by the Quality Operations Supervisor.
Monitor manufacturing process for adherence to product requirements.
Conduct analytical testing to confirm product meets specifications to include: pH, LOD, viscosity, etc.
Visually inspect manufactured product to meet AQL requirements.
Initiate Non-Conformance and CAPA investigations.
Assist with testing, monitoring and/or reporting on biological and air testing of the controlled environmental areas, stability testing, or calibration as required.
Complete all documentation with clear and accurate language and according to the Standard Operating Procedures.
Provide clearly written technical documentation.
Work with various teams to correctly identify root/probable causes and develop appropriate corrective/preventive actions to eliminate/mitigate the issue.
Revise related SOP's with the guidance of the Quality Operations Supervisor.
Perform and assist in internal assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
Participate in manufacturing site projects in the role of contributor.
Education and/or Experience:
BS/BA in Chemistry, Biology or related field or related experience required.
Fresh Science graduates encouraged to apply.
Requires Vision Assessment: 20/20 near visual acuity w/ acceptable color vision
Familiarity with incoming, in process and final testing procedures as well as demonstrating hands on experience using a wide range of USP compendial procedures.
Familiar with ISO 9000/ISO 13485 Quality System Standards, FDA Quality System Regulations, GMP’s and/or other international medical device regulations.
Familiarity with material, biocompatibility and microbiological testing methods for the evaluation of materials and finished medical devices.
Testing to clean room environmental specifications and monitoring methods.
Computer skills including those associated with word processing, spread sheet programs, databases and statistical analysis.
Ability to prepare testing protocols and reports, operating documents and procedures.
Ability to work with little or no supervision and make effective decisions.
Ability to communicate effectively and follow detailed written and verbal instruction.
Cooperate with coworkers within an organized team environment or work alone without supervision.
Manage time effectively to complete assignments in expected time frame Familiarity with general laboratory and incoming supply inspection testing is required.
Familiarity with Pycnometer Density determination, pH, Viscosity, Loss on Drying, and Particle Size analysis is desired (Lab testing).
Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution.