QA Technician

Company: Apex Life Sciences ( Learn More )

General Information
US-WI-Madison
N/A
4 Year Degree
Full-Time
Not Specified
Not Specified
False
False
Job Description

POSITION SUMMARY

The Quality Assurance Associate participates in the design, creation, implementation and monitoring of programs and methodologies to ensure that  products meet established specifications, design criteria, quality standards and customer requirements.  Leads internal audits and identifies continuous improvement opportunities and helps implement corrective actions.  QA Associate II provides sustaining quality support for on-market products as assigned.

ESSENTIAL JOB DUTIES 

Key Responsibilities of the Job: 

•             Acts as Quality representative for change control and Material Review Board (MRB)
activities of on-market products as assigned

•             Review records for product release and documents for completeness & accuracy under a production schedule

•             Review and update (as authorized) quality system documentation

•             Log, file, maintain and archive various QA reports & records

•             Track key performance metrics

•             Prepares and presents material for the monthly Instrument & Reagent Quality Review meetings

•             Identifies, investigates and works with other departments to resolve quality issues

•             Leads internal compliance audits to established Quality System Manual and applicable regulations and standards

•             Participates in supplier audits and other supplier quality activities as assigned

•             Identifies continuous improvement opportunities and works cross-functionally to implement corrective/preventive actions

•             Other duties as assigned 

JOB REQUIREMENTS 

Competencies:  
•             Learning on the Fly—learns quickly/open to change

•             Organizational Agility—knows how to go through the proper channels to get things done 
•             Peer Relationship—cooperative, team player, trusted and supported by peers

•             Planning—sets specific goals and objectives, ability to plan for the length and difficulty of assignments, ability to break down projects into specific tasks/steps

•             Priority Setting—focuses on what is most important

•             Written Communications—effectively communicates in writing 

Required Education/Training:  

•             Bachelor degree required, in a science/engineering discipline preferred 

Required Certifications/License/Special Skills: 

•             Good verbal and written communication skills

•             Certification in a quality discipline preferred, such as CQT, CQA, CQE, etc.

•             Computer skills (Microsoft Windows and Office programs), familiarity with Oracle
preferred 

Required Work Experience:

•             Experience in an Good Manufacturing Practices (GMP) environment preferred

•             Experience with participating in formal audits preferred

•             Minimum 5 years’ experience in Manufacturing environment, previous Quality experience preferred  

WORKING CONDITIONS         

•          
•             Work is normally performed in a typical manufacturing work environment  
•             Possible exposure to mechanical, biologic and chemical hazards 
•             Frequent use of personal computer, copiers, printers, and telephones  
•             Frequent standing, walking, sitting, listening, and talking 
•             Frequent work under stress, as a team member, and in direct contact with others 
•             Occasional lifting of 30 lbs. and climbing 

Physical Requirements: 

•             Lifting/Use of Strength is Medium (20 to 50 pounds)

•             Climbing on the job is required:   Occasionally--Up to 33% of the time

•             Kneeling on the job is required:  Occasionally--Up to 33% of the time

•             Reaching on the job is required:  Occasionally--Up to 33% of the time

•             Stooping on the job is required:  Occasionally--Up to 33% of the time

•             Vision (Color) on the job is required:  Occasionally--Up to 33% of the time

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.

Job Requirements