Job Control Language Setup Specialist jobs in Hialeah, FL

Department: Quality Assurance

Reports to: Quality Assurance Management

Description:

• Maintain documentation to ensure compliance with internal procedures and regulatory requirements
• Maintain electronic document control system to ensure prompt retrieval of documents
• Performs document control functions, including document review, editing, tracking, processing, approval, distributing, issuance and archiving in compliance to internal and external requirements
• Possess proficient writing and literacy skills
• Ability to write Change Control reports, Incident reports, Deviation reports, and Investigation reports.
• Maintain the review and follow through with electronic document packets for processing in Master Control
• Review documentation for accuracy and conformance to established guidelines, policies, and practices
• Maintain control and confidentiality of documents and information
• Conducts periodic reviews of all documents to maintain consistency to customer, corporate, regulatory, or standard requirements.
• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste
• Write or assist with the development of procedures and work instructions
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards
• Maintain filing, record retrieval, archival, and disposition.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards
• Establish working relationships with document management coordinators locally and with other facilities.
• Support business unit and corporate harmonization initiatives per the quality management system
• Use independent judgment, as necessary, in developing systems/processes for use within Quality Systems
• As appropriate, take initiatives to improve the effectiveness and/or efficiency of quality systems
• Develop training material and perform training for document and record control.
• Provide support with internal / external audits to include monitoring audit findings.
• Audit facilities/departments for compliance to the documented QMS and cGMP requirements
• Contributes to continuous process improvement efforts
• Perform training for document and record control. Perform other duties, as assigned.

Required Knowledge and Experience:

• Must have effective problem solving and interpersonal skills.
• Prior QA and QC experience preferred.
• Ability to read, write and follow verbal and written instructions.
• Ability to accurately collect and organize data. Must be computer literate in Microsoft Office, Master Control, Excel, Power point etc…..
• Must be able to perform basic mathematical functions using whole numbers, fractions, and decimals. Must be able to compute averages, rates, percent and to draw and interpret bar graphs.

Educational Requirements:

- Associate degree in technical or business-related field / Bachelor’s degree preferred.

- Minimum 3 years of experience working in Pharmaceutical company as QC- Document Control Supervisor.

SALARY NEGOTIABLE DEPENDING ON EXPERIENCE, QUALIFICATIONS, AND RESPONSIBILITIES

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Relocate:

• Miami Lakes, FL 33014: Relocate before starting work (Required)

Work Location: In person