Quality Assurance Specialist jobs in Pembroke Pines, FL

Description

Scope of Function:

Quality Assurance employee will assist with all aspects of document control including issuing process records, label creation, maintaining the training database as well as QA final disposition pertaining to manufacturing processes. Work closely with manufacturing operations, facilities and business operations as well as working closing with Quality personnel. 

Reports to: 

Director of Quality / Regulatory

Specific Duties: 

Format all regulated documents as per SOP, create WIP, package and patient labels for manufacturing purposes. Maintain the training matrix/database as well as individual files. Sort, scan, file regulated documents including process records, protocols, and SOP’s/Policies. Assist with annual document review process. In addition, this role will write/revise documents as required. Perform QA release of components and raw materials received as well as assist with final shipping pull, pick and pack of released product to be distributed.

Requirements

Education and Experience Required:

• High School Diploma or AA degree
• Three years’ experience in a pharmaceutical manufacturing environment or related industry focused on quality operations OR one to five years of experience with requirements within a related, regulated environment.
• Experience with AATB accreditation and/or FDA 21CFR1271 regulations preferred, but not required.
• Must be a Subject Matter Expert in Microsoft Office, including Word, Power Point and Excel

Other Skills and Abilities:

• Self-motivated individual who can work in a multi-disciplinary team.
• Good troubleshooting, communications, teamwork and team leading skills.
• Able to lift to 35 pounds

Qualifications:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Must have solid teamwork skills to interface with doctors, technicians, suppliers, and analysts to ensure smooth production and plant operations.

Safety/Personal Protective Equipment (PPE):

• Adhere to company safety policy and PPE policy.
• Participate in the Safety Program for the site as QA has oversight of all Safety