Performs necessary duties to evaluate assemblies and finished products to ensure conformance to drawing requirements, specifications and approved procedures. This position is responsible for ensuring that good manufacturing practices and good documentation practices are maintained in manufacturing, the coordination of the non-conforming materials process, and the review of electronic and paper Lot History Records.
Essential Duties and Responsibilities:
Performing in-process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GMP) for commercial and clinical product in a timely matter.
Maintain compliance with operating procedures and ensure training is completed prior to the operation of a task.
Ensure all documentation is legible, complete and correct per current Good Manufacturing Practices (GMP).
Inspect labeling for the finished product.
Understand and perform line clearance activities in manufacturing.
Perform in-process quality audits in manufacturing to assure compliance to manufacturing documentation and good documentation practices.
Assist with the NCMR process during manufacturing of commercial and clinical product.
Demonstrate good computer skills and perform computer operations to generate reports and graphs using Microsoft Word and Excel.
Perform in-process product inspection and testing for commercial and clinical product.
Must be able to distinguish between certain colors and pass an annual color vision test
Familiarize yourself with the manufacturing processes.
Review shipping documentation to assure accurate order shipment.
Works closely with Research & Development, Regulatory Affairs, Clinical, and Manufacturing groups.
Provide training for new employees
Takes on new challenges and expanding roles to assist with growing demands within different areas of the Quality Department.
Must have strong organization skills and attention to detail
Assumes and performs other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ideally has past experience working with the following; Agile, Oracle and/or Camstar software programs.
Must be able to communicate effectively in English. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be required to perform the following Physical Activity: Standing, walking, sitting, using hands, handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear, taste or smell. May be required to lift 0 lbs. to over 100 lbs.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be exposed to the following environmental conditions: Wet or humid conditions, work near moving parts, work in high - precarious places, fumes or airborne particles, toxic or caustic chemicals, outdoor weather conditions, extreme heat (non-weather), extreme cold (non-weather), risk of electric shock, work with explosives, risk of radiation, vibration. The noise level in this work environment can range from quiet to very loud.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at email@example.com.
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