Quality Systems - QS Associate I & II-Batch Record Author

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

Description

Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications.

• Prepare, issue, scan, and file quality documents.
• Manage the document life-cycle including, but not limited to, issuing templates, reviewing and revising documentation, and routing documents for approval and qualification.
• Ensure quality documents accurately reflect current procedure.
• Translation of customer specifications into Accupac documentation.
• Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization.
• Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
• File and archive documentation.
• Perform other duties as assigned.

• Comply with all company policies, SOP’s, current Good Manufacturing Practices and other relevant regulatory requirements.
• Maintain training at or above 90% of assigned curriculum.
• Possess Good Documentation Practices.
• Possess a working knowledge of MS Office applications (word, excel, etc.)
• Attention to detail.
• Ability to work individually and in groups.
• Interpersonal skills.
• Ability to perform basic math skills.
• Ability to read, write and understand English.
• Effective communication skills.
• Meet deadlines as assigned.
• Ability to read, inspect and match batch codes.
• Possess a working knowledge with the use of balances, torque meters, vacuum/seal strength testers, and computer.
• Demonstrate the ability to be flexible to changing requirements and duties of the position.

• Ability to lift up to 40 lbs.
• Walking within the confines of the facility.
• Standing up to 80% of designated shift time.
• Good hearing (ability to hear alarms, ringing).
• Ability to bend/kneel to verify components.
• Ability to see colors and good sense of smell.
• Peripheral Vision.

No

None

The QA Associate I must have a college degree and 0-2 years of Quality Control/Assurance experience in related field and LIMS experience. The QA Associate II must have a college degree, 2 plus years of Quality Control/Assurance experience in a related field and LIMS experience.

• Full-Time/Part-Time:
  Full-Time
• Shift: Second
• Position: QS Associate I & II-Batch Record Author
• Location:
  
  Mainland
• This position is currently accepting applications.