QA Technician in Cuyahoga Falls, OH at Apex Life Sciences

Date Posted: 6/3/2018

Job Snapshot

Job Description


APEX Life Sciences is looking for an entry level QA Associate to work with one of our Clients in the chemical industry.  If you are interested in getting into Quality Assurance, Apply Today!!

2nd Shift Opportunity - Needs to be able to train on 1st shift.

Required Duties and Tasks

Expected Business Results are the areas for which this role is responsible. These Expected Business Results should logically fall under one or more of the Critical Success Factors.

Quality

  • cGMP compliance with relevant cosmetic and drug regulations.
  • Initiation of investigations in response to out of specification test results.

Customer Satisfaction

  • Verification that product meets expected specifications.

Financial Strength

  • Verification that appropriate control processes have been followed prior to sale or shipment of products.

Essential Job Duties:

Key activities that a person in this role engages in with frequency or criticality

  • Releases quarantine Products to Distribution at on-site and off-site storage facilities.
  • Releases Quarantined product for Canadian Distribution.
  • Coordinates OCV products from testing to reconciliation.
  • Generates Certificates of Analysis for in-process and finished goods as requested.
  • Provides documentation for International product registrations.
  • Generates Certificates of Analysis and Quality Reports for Japanese Distribution.
  • Provides training for new employees, on new methods and for cGMP procedures.
  • Leads investigations for OOS (out of specification) values.
  • Maintains QA Balanced Scorecard weekly.
  • Verifies labels to be used in manufacturing process.
  • Participates on new product launch teams.
  • Participates in New Product Launch Reviews and in Annual Product Reviews.
  • Conducts data analysis; coordinates data review and acceptance.
  • Assists with stability and retain programs.
  • Generates data reports including regressions used to calculate expiration dates.
  • Engages in problem solving activities.

Duties may also include:

  • Issuance of Expiration codes, standard fill targets, special customer requirements on a regular basis.
  • Publication of Quality System Scorecard.
  • System and procedural audits.
  • Track and initiate action based on Deviation reports.
  • Back-up support to other areas of QA.
  • Special data review and reports

Accountabilities: (include planning, programs, performance, quality and policies)

  • Knowing about products and specifications
  • Timely completion of tasks and reporting of results
  • Data analysis
  • Testing support for weekends, overtimes and periods of heavy business
  • Verbal and written documentation
  • Adherence to safety
  • Adherence to procedures
  • Provides technical training resources
  • Quality of documentation 
  • Finished good release and shelf life storage 
  • Participating in the PMP including monthly one on ones; providing Accurate Shop Floor Information