Quality Assurance Documentation Specialist

• Base Pay $24.00 - $25.00 / Year

AWT is a leading manufacturer of custom labels, flexible packaging, and precision converting solutions servicing Healthcare, Consumer Brand, and Technology clients worldwide. AWT employs nearly 650 associates and operates facilities in Minneapolis, MN (Headquarters), South Elgin, IL, Hauppauge, NY, Grand Blanc, MI, Anaheim, CA, Ottawa and Toronto, Canada, Winston-Salem and Garner, NC. AWT is the trusted partner for leading brands, delivering comprehensive, innovative, and sustainable solutions with exceptional quality, expertise, and responsiveness.

More information about AWT can be found at

AWT offers comprehensive benefits including medical, dental, vision, life insurance and other voluntary supplemental insurance coverages, HSA, 401k with match, holidays and paid time off.

AWT has the following position open in our Hauppauge, NY location:

The schedule for this position is M-F, Hours are - 8am - 4:30pm. Additional days and hours may be necessary due to production requirements.

The basic function of the
Quality Assurance
Documentation Specialist
is to ensure the functions in the Responsibilitiessection are performed in an effective manner in regard to the reviewing of documents found with a batch record at AWT Labels & Packaging, Healthcare.

• Pharmaceutical background preferred.
• Well organized.
• Must possess a high level of energy.
• Possess good communication skills.
• Accuracy in checking and recording.
• cGMP experience preferred.
• Possess extreme attention to detail.
• Has the ability to work independently.
• Must have computer skills with a working knowledge of MS Office applications.
• Math
  :
  Must be able to add, multiply, divide, subtract and handle measurements.
• Language
  :
  Must be able to communicate verbally and in writing in English to interact with co-workers.
• Spatial
  :
  Must have excellent eyesight, hearing, and depth perception.

Requirements

• Specific training is given for the first thirty (30) days but not limited to those thirty (30) days.
• Ongoing Safety training, as needed.
• Ongoing cGMP training will be part of the Quality Assurance program.
• Ongoing SOP training will be conducted, as needed.
• All training seminars are to be documented and signed by Instructor.
• All new procedures will have a formal training session prior to being utilized by the company, unless otherwise noted.

• Reports directly to Manager, Quality Assurance.
• Assists with performing final batch record review, including, but is not limited to:
• Proper use of Folder Tracker Program before and after review of a batch record.
• Verifies completeness for signatures on all forms found within the batch record.
• Verifies the correct paperwork is contained and included within the proper folders within the batch record, including QA Vision reports.
• Verifies the retention samples for all treatment groups are held within the batch record.
• Secures (staples) the paperwork/documentation in proper order.
• Ensures that customer specific requirements are adhered to within the documentation presented.
• Must be able to review batch records in a timely manner.
• Assists with the checking and verification of Packing Slips and Certificate of Compliances, also known as “paperwork checks”, to ensure that all information is complete and correct on said documents, including, but not limited to:
  • Customer name and address.
  • Project number.
  • Protocol name and/or numbers.
  • Contents of packages (line by line entry of treatment lots).
  • Purchase Order numbers (PO #).
  • Lot numbers of components used.
  • Expiration dates for the company’s warranty, etc.
  • Pack IDs.
  • Shipper Labels.
• Communicates with other employees within the QA Department and those in other departments within the company.
• Performs any additional tasks needed to assist the company with the day-to-day operations.
• Performs any tasks or duties as assigned by the Manager, Quality Assurance to assist the QA Department with the day-to-day operations.

AWT is an Equal Opportunity Employer and we encourage all qualified and interested persons to apply for available positions by submitting an application or resume for consideration. AWT will not discriminate against any applicant or employee based on race, color, religion, sex, gender identity or expression, national origin, ancestry, age, disability/handicap status, marital status, military status, sexual orientation, genetic history or information, or any other basis protected by federal, state and local laws.

It is AWT's policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.

Please note these job descriptions are not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.