Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Position Summary:

Responsible for all quality control aspects of finished product testing. Supports QC leadership to coordinate the operation of the Quality Control Laboratory. Ensure that performance of finished product is in compliance with testing standards per IFU and SOP's in addition to customer requirements and regulating agencies' guidelines. Responsible for developing and driving productivity projects for the quality control lab.

Key Responsibilities:  

Review and maintain product compliance specifications, documentation control.Assist QC leadership with daily problem bench reviewInitiate out-of-specification investigations in MastercontrolWrite and implement protocols for site requested product investigations and raw material testing.Write and implement protocols for lab productivity projects.Provide lab bench coverage in the event of absence.Lead and facilitate continuous improvement program within department.Initiate Issue Review’s and implement root cause counter measures as advisedMaintain consistent training in Master Control.Create, update and maintain SOP’s for lab procedures in Mastercontrol in accordance with FDA and ISO regulations.Update inspection plans in SAPExercise and monitor GLP compliance in work environment.Work closely with Quality Assurance department as a quality team to provide up to date product information.Work closely with a team in a fast-paced laboratory setting.Understand and exercise all safety requirements and procedures.Participate in achieving department goals.Support all company policies.Fulfills additional responsibilities as needed.

Minimum Requirements/Qualifications:

Possess a 4-year degree in the biological sciences – microbiology preferred4 years microbiology lab experience preferredFamiliarity with plate and tube media.Familiarity with FDA regulations for medical devices.Understanding of USP and CLSI requirements.Possess the ability to manage many tasks and in an organized fashion.Able to communicate effectively with a variety of departments in regard to quality testing parameters.Possess digital literacy - experience in Microsoft Office to include Word, Excel and Power Point programs. Experience working in SAPListen to, and follow, written and verbal instructions.Able to adapt and to learn new procedures and to maintain a scientific and objective approach.Must be available to adjust work shift when needed.Self-motivated, highly responsible and possess a good team work spirit.Excellent verbal and written skills in English.