Quality Analyst (Evenings 2pm to 10:30pm)

LOCATION: Onsite at LSI Solutions in Victor, NY

ESSENTIAL FUNCTIONS:

Level I

• Process paperwork accurately and neatly.
• Work in Cleanroom Environment.
• Maintain consistent quality and workmanship.
• Conduct detailed records review.
• Search and locate documents in Grand Avenue Software (GAS).
• Perform all process steps within 2 product families.
• Properly transact materials in ERP system.
• Conduct inspection and in-process audit of material status throughout product realization.
• Ensure enforcement of good documentation practices within Device History Records.
• Originate Nonconformance reports.
• Segregate and control non-conforming product.

Level II

• Perform Level I functions efficiently and effectively without continuous supervision.
• Understand and support Cleanroom and Quality System processes.
• Participate in the creation of metrics reports with Quality Engineers.
• Maintain databases to support metrics reporting.
• Participate in developing standard work instructions.
• Assist in internal audits, as necessary.
• Suggest process and system continuous improvements.
• Participate in Continuous Improvement Teams.
• Support Quality Engineers in project completion.
• Perform PM activities (i.e. bioburden, environmental monitoring).

Level III

• Coordinate Nonconformance reports.
• Assist in supervision of staff and monitoring productivity.
• Assist in training of new employees and coaching existing employees.
• Assist team members. Be helpful and encouraging.

ADDITIONAL RESPONSIBILITIES:

KNOWLEDGE, SKILLS & ABILITIES:

Level I:

• Excellent verbal and written communication skills with various levels of management and coworkers.
• Demonstrated ability to follow instructions, both written and verbal.
• Able to communicate effectively with cross-functional teams in a manner that supports internal and external customers alike.
• Ability to exercise independent judgement as well as work alongside team members.
• Demonstrated proficiency using Microsoft Office applications including Excel.
• Working knowledge of ERP systems and other electronic databases.
• Maintain good and cooperative relationships with colleagues involved in other aspects of the process or operations in order to promote strong teamwork.
• Attention to detail, technical aptitude, and process-oriented troubleshooting skills necessary.

Level II:

• Able to create metrics, maintain databases, analyze and recognize trends and inconsistencies.
• Experience with continuous improvement efforts of systems and processes.
• Familiarity assisting with quality audits.

Level III:

EDUCATION & EXPERIENCE:

• Associate degree in a technical discipline preferred.
• High School Diploma or equivalent and 2 years of demonstrated success in a highly regulated manufacturing environment acceptable in lieu of Associate degree.
• ASQ CQPA or CQA Certification preferred.
• Familiarity with GMPs, Quality Standards, and Regulatory Compliance is highly desired.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Sitting, standing and/or walking for up to eight hours per day.
• Frequently required to lift and/or carry up to 40 lbs.
• Regularly required to talk and/or hear, see, see color, perform repetitive motion and reach.

Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.