Quality Control Analyst - Phoenix in Phoenix, AZ at Apex Life Sciences

Date Posted: 2/10/2018

Job Snapshot

Job Description

QC Microbiology/Environmental Control Associate Analyst

3rd Shift: 10:00pm to 6:30am

Weekend work & OT: Candidates must be open to overtime

Purpose and Scope of Position:

The QC Environmental Control Associate Analyst works both independently and with the team to collects, analyzes and trends environmental monitoring results for the Controlled non-aseptic area, aseptic area, compressed gases, and aseptic personnel.

Education and Experience:

  • High school diploma or equivalent required
  • 1 year of relevant work experience required, preferably in a regulated manufacturing environment with cGMP requirements
  • An equivalent combination of education, experience and training may substitute

Required Competencies: Knowledge, Skills, and Abilities  

  • Requires the ability to deal appropriately with regulatory agencies  
  • Ability to multi-task and work flexible work schedule
  • Basic written and verbal communication skills
  • Basic ability to interpret general business documents
  • Basic Problem-solving skills
  • Ability to work cooperatively as an individual contributor and as a team member
  • Ability to gown and maintain a sterile work environment
  • Ability to work independently for extended periods of time
  • Basic proficiency in Microsoft Word, Outlook, and Excel
  • Basic knowledge of cGMP, OSHA, DEA, USP, and EP
  • Ability to pass an initial full physical with annual monitoring

Duties and Responsibilities:

  • Collect environmental monitoring samples:
  • Collect viable and non-viable samples within controlled environments
  • Collect viable and non-viable samples for compressed gases
  • Collect personnel glove and gown samples
  • Participates in aseptic process qualifications:  
  • Aseptic gowning
  • Media fills Documents, Tracks, and Trends test results:
  • Record daily data results
  • Prepares spreadsheets of data
  • Training: Assist in the creation of controlled and aseptic area training modules
  • Performs other tasks as assigned

Working Conditions:

  • This position involves being fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, balancing, pushing, pulling, lifting (NMT 25lb), or carrying (NMT 25lb)
  • This position works within controlled environments with strict gown and gloves requirements
  • This position involves working conditions with constricted personnel movements for up to 6 hours a day

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 employeeservices@apexsystemsinc.com or 844-463-6178.