QUALITY ASSURANCE TECH - SRI Healthcare, LLC

Job description

SUMMARY

Assist Quality Assurance Supervisor in the duties of quality inspection and control at facility-level.

POSITION RESPONSIBILITIES:

• Ensure quality control functions are performed according to written Standard Operating Procedures and GMP.
• Assist with the facility training of employees, annual updates and other required instruction as needed. Programs include but are not limited to, blood borne pathogens, lock-out tag-out, right to know and evacuation procedures.
• Assist with the maintenance of the Medical Device Records log; distribution and control of all related documents.
• Maintain sterility release records and coordinate release of individual loads and disposable accessory packs.
• Assist with the product complaint program as directed by the Q. A. Supervisor.
• Responsible for in-process inspections, instrument inspection, dispositioning of components and product audits as directed by the Q. A. Supervisor.
• Audit job performances to ensure SOP/GMP compliance.
• Assist with bio-burden and airborne environmental sampling.
• Other duties as assigned.

EXPERIENCE: Minimum of 2 years of quality assurance or quality control training and/or experience preferred. Prior experience internal to Synergy Health will be considered in lieu of direct previous quality assurance responsibilities.

EDUCATION: High school diploma or GED required. Two-year Degree preferred.

KNOWLEDGE, SKILLS, ABILITIES:

• Must be detailed-oriented.
• Verbal ability to assertively interact with all levels of personnel including senior management on quality matters.
• Ability to manage time and work with minimal supervision
• Well organized with ability to maintain precise records.
• Knowledge of computer programs, word processing and spreadsheet
• Excellent written communication skills
• Flexible in work hours.
• Ability to communicate effectively with supervisors and coworkers.
• Ability to read and understand applicable Standard Operating Procedures.

SUPERVISORY RESPONSIBILITIES: None

WORKING CONDITIONS: Indoor plant environment with occasional exposure to uneven temperatures, bio-hazardous materials and strong odorous chemicals and/or other elements.

TRAVEL REQUIRED: None