QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsabilities:
- Assists in implementing and supervising daily activities in the manufacturing area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that apply.
- Leads and audit manufacturing employees over daily/weekly/monthly production plans requirements assuring product quality in compliance with company expectations.
- Monitors and control labor efficiency, downtime, scrap, conversion loss and other key performance indicators.
- With the direction of the Supervisor, coordinates the manufacturing activities to accomplish the goals.
- Assigns employees to specific jobs/job rotations and monitors personnel performance. Provides feedback to supervisor/manager and director concerning employee job performance.
- Aids and assists in equipment troubleshooting problems.
- Informs Supervisor/Manager and fills out reports on manufacturing activities (daily, weekly, monthly, annually) on a timely basis as required.
- Audits manufacturing areas assuring compliance with specifications, batch record documentation and procedures.
- Reviews, make changes and supports implementation of changes to specifications and SOP's.
- Audits and implements procedures and policies in all areas under responsibility assuring compliance and training in cGDP's, specifications, SOP's, procedures and/or training manuals.
- Supports and assures compliance with all the Operational Excellence projects implemented in his/her area.
- Performs and coordinates area changeover.
- Assist the Supervisor with the payroll adjustment to Supervisor for approval. Assure that work schedules of manufacturing employees in his/her area of responsibility are correct in Kronos.
- Serves as backup to other Lead Operators
- Conducts periodic meetings with employees as required.
- Collaborates in the investigation and solution of quality issues and complaints.
Qualifications:
- Bachelor's or Associate degree preferably in Science, Engineering or Technology.
- 3 years of experience in a manufacturing process, preferably in pharmaceutical/solutions filling manufacturing environment
- Strong writing skills and ability to prepare reports, write business correspondence and procedure manuals in English.
- Ability to understand GMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
- Strong analytical, problem solving and troubleshooting skills.
- Computer literate.
- Hands-on experience on computer programs, such as MS Word, Excel, Powerpoint
- Domain of the English and Spanish languages
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.
Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
