Quality Assurance / Document Control Associate
CATEGORY Quality Assurance
We are seeking a highly motivated and organized Quality Assurance / Document Control Associate to join our team! The Associate is responsible for providing administration support to the Quality Assurance and Document Control department.
5 Key Responsibilities
Create/revised and released change order
Process Document Request
Create and update Production binders
Scanning Training Record and upload to QCBD
ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING. OTHER DUTIES MAY BE ASSIGNED.
Maintain cooperative, diplomatic working relationships with co-workers, manager and the public.
Work as part of the team and collaborate with co-workers and colleagues.
Responsible for reading, understanding and following Quality Systems documentation for each function performed.
Responsible for working in compliance with Quality Systems Regulations (QSR), safety and all other training.
QA/Document Control Administration
Responsible for managing, and maintain company documents, while ensuring the accuracy and quality of them. This job includes tasks such as processing documents for revision and approval, organizing documents from conception to distribution and filing, and creating systems which can be used to train staff on document control process.
Responsible for scanning documents, then organize them to maintain them, adhering to the company's document lifecycle procedures, any inactive documents and records are then archived.
Document Control may take on a variety of duties, depending on the project and the organization based on the job priorities.
Responsible for providing document creation support: ensure all documents are written and formatted according to company procedures and SOPs to describe other users how to use the template when creating documents for their area.
Responsible for ensuring the documents are revised/released and processed in a timely manner, according to the change order process and department processing time goals.
Responsible for issuing Part Number and Document Number by working with Marketing and Engineer.
Responsible for assisting in QA and Document Control functions including processing Change Orders, Training Records, Deviations, Customer Complaints, and NCMRs.
Responsible for maintaining a clean and safe work environment by identifying all safety hazards and recommending corrective actions when necessary.
Responsible for understanding chemical hazards and interactions.
Responsible for utilizing proper lifting and material movement techniques, always.
Adhere to and support Corporate Policies and Procedures.
Actively works to improve processes in the company and its relationship to the community.
Performs all other related job duties as assigned by the QA/Document Control Supervisor.
Desired Skills and Experience
Zero to Two (0-2) years of experience are required, any experience in Quality Assurance and Document Control is a plus.
High School diploma required.
Bachelors degree in science related field is preferred.
0-1 year work experience in a Quality related role is preferred.
0-1 year work experience in medical device/regulatory environment is preferred.
Batch Record/Device History Record review experience and/or Document Control experience is a plus.
Ability to read, write and speak fluent English.
Able to recognize and resolve problems quickly using sound judgment and diplomacy.
Computer literate in a Windows Environment: Excel, Word, OneNote, Internet, especially Excel in order to log / analyze data.
Good organizational skills.
Legible handwriting for laboratory notebook keeping.
Flexibility to change gears with little notice.
Ability to be a team player.
Ability to lift up to 35 pounds.
Good visual color perception.
Able to stand, stoop and bend.
Able to sit at desk and use/view computer for prolonged periods of time, up to 9.5 hours daily.
Fast paced with multi-level distractions.
Professional, yet casual work environment.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.