Leading Biotechnology company has an immediate opening for a QA Associate. This position is 20 hours per week, with tasks that include inputting information on excel or word documents, scanning documents/archiving documents, organizing and maintaining document control, filing documents, and working closely with the Document Control team.
SUMMARY:
The QA Associate I is responsible for performing a wide variety of routine and semi-routine activities pertaining to assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements. The Associate I promotes a cGMP environment and collaborates with internal team members to ensure adherence to specifications, processes, and procedures. The Associate I performs documentation review and ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems. Understanding and execution of basic cGMP and GDP principles is required.
ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:
Performs cGMP documentation/data review (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records.
QMS process support for change controls and quality investigations.
Performs AQL inspection of final filled product.
Performs area line clearance operations in support of manufacturing operations.
Provides QA oversight and performs real time, on-the-floor documentation review during manufacturing operations.
Generate labels for cGMP use.
Reviews, approves, and reconciles labels for cGMP use.
Sterile gown qualified to support cGMP activities in sterile suites.
Assists in the review and data entry of Calibration and Preventative Maintenance records.
Assists in the review of equipment and facility related Change Control documentation.
Maintains equipment files and archives.
Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies Company's cultural values and aligns daily actions with department goals and company culture.
EDUCATION AND EXPERIENCE:
High School Diploma or equivalent required. Bachelor’s degree in a Life Sciences discipline preferred
Zero to two (0-2) years of relevant experience in documentation, QA, or equivalent.
Knowledge of cGMP regulations and good documentation practices preferred.
Experience with Computerized Maintenance Management Software (CMMS) preferred.
Demonstrated ability to follow detailed directions in a laboratory environment preferred.
Ability to work independently, within prescribed guidelines, and as a team member
While performing the duties the employee is:
constantly required to sit, and to reach to use computers and other office equipment
constantly stand for extended periods of time, up to four (4) hours/time.
frequently required to lift up to 50 pounds
constantly required to view objects at close and distant ranges with hand and eye coordination
frequently required to communicate with others
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
VISUAL DEMANDS:
This position includes essential tasks that experience and applicable standards show require 20/20 vision (natural or corrected) in order to perform the position in question. This position also requires the ability to see and differentiate among colors.