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.
Responsibilities:
- Work in a dynamic production environment at site supporting development, clinical, and launch activities.
- Under general supervision, employee will perform operations in the Manufacturing area.
- Operations will be performed according to Standard Operating Procedures (SOPs).
- Performing in-process sampling of equipment and operating analytical equipment
- Performing washroom activities: clean small- and large-scale equipment used in production activities.
- Maintaining an organized and clean workspace
- Initiating quality reports
- Drafting and revising documents (SOPs, MPs)
- Assisting in the review of documentation for assigned functions (equipment logs, batch records)
- Working around high-pressure systems and occasionally work around heavy equipment.
- Execute routine validation protocols
Qualifications:
- Bachelor's Degree in Life Sciences, Chemistry, Biology, Chemical Engineering Biotech, Biochem, etc.
- Manufacturing experience.
- 4 years of Manufacturing experience
- Experience in Set-up, cleaning, and sanitization of various manufacturing equipment
- Experience in preparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
- Knowledge of GMP documents (SOPs, MPs) with strict adherence to safety and compliance
- Ability to work in a manufacturing plant environment wearing steel toe shoes, lab coat, safety glasses and gloves when performing all work.
- Must be available to work various shifts (Days, Swings, Graves, Weekends, Holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule 4 x 10 Sun – Wed or Wed – Sat, Days or Swings. 4 x 12, 3 x 12 Sun-Tues/Wed or Wed/Thurs- Sat, Days or Graves.
- Shift flexibility is a must as this will vary depending on the manufacturing model/ business needs
- Experience following an SOP
- Experience working in a high change/ high volume environment
- GMP experience preferred not required
- Manufacturing experience highly preferred
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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Last updated on Nov 18, 2024