Job Description:

The primary responsibilities of this role include quality review of supporting documentation completed for production, testing, labeling, and shipping in order to determine if all critical process parameters (CPPs) and critical quality attributes (CQAs) have been met. Upon completion of review, this individual will determine if the evidence supports release of associated materials and if the materials are suitable for use and shipping.

Responsibilities

• Responsible for the review of supporting production and testing documentation for completeness and accuracy. This individual must be able to identify deviations from procedure and confirm that all quality events have been appropriately investigated and closed related to the documents reviewed


• Responsible for tracking incoming documentation and document movement within the Quality Assurance Department


• Support Quality Assurance team by assigning appropriate tasks within required tracking tools and Quality Management System to support lot release


• Work with staff across multiple departments during review, correction, and finalization of documentation


• Responsible for tracking and trending of documentation errors


• Ability to manage multiple documents simultaneously that are in different stages of review and/or approval

Required Skills

•  Strong attention to detail


•  Organized and able to manage multiple assignments of varying priorities at one time


•  Accurate in their work


•  Critical thinker with strong decision-making skills


• Effective communication and interpersonal skills across all functions

Must-Haves

• 0-1 years Quality Assurance or Regulatory Compliance experience in GxP environment is a plus


• Bachelor’s (or equivalent) degree in science or related field or equivalent experience

Work Hours/Shift

Monday-Friday – 8 am – 5 pm

Working Conditions/Physical Requirements

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers/filing cabinets and fax machines.

While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand; walk; bend; lift up to 50 pounds; use arms, hands and fingers for various activities.  This position may stand or remain sedentary for long periods of time.  This position routinely works with large pieces of equipment.

Join Us Today!

Join a team committed to making lives better. Aldevron provides high-quality plasmid DNA, proteins, enzymes, antibodies, and other biologics to help our partners achieve significant breakthroughs for a variety of life science applications.

If you would like to thank someone for referring you to this role, please apply at www.aldevron.com/careers, and include their first and last name as a referral source!

Aldevron is committed to equal opportunity for all employees and applicants. We are committed to creating a diverse workforce and consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identify, or protected veteran status among other factors.

 

 

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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