Analysis Skills, Biology, Biotech and Pharmaceutical, Chemistry, Communication Skills, Consulting, Current Good Manufacturing Practice (cGMP), Documentation Review, Drug Products, Film, GMP (Good Manufacturing Practices), Identify Issues, Interpersonal Skills, Leadership, Manufacturing, Manufacturing Equipment, Medical Equipment, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product/Service Launch, Quality Assurance, Regulatory Compliance, Reporting Skills, Safety Compliance, Safety/Work Safety, Standard Operating Procedures (SOP), Team Player, Technical Support, Writing Skills
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:
- Set up, clean, and sanitize various manufacturing equipment.
- Perform washroom activities for small and large-scale equipment.
- Prepare buffers and media per manufacturing procedures (MPs) and SOPs
- Monitor critical processes and perform basic troubleshooting.
- Conduct in-process sampling and operate analytical equipment.
- Follow GMP documents (SOPs, MPs) with strict adherence to safety and compliance.
- Initiate quality reports.
- Draft and revise SOPs and MPs.
- Review documentation such as equipment logs and batch records.
- Maintain an organized and clean workspace.
- Maintain a safe environment while adhering to compliance standards and by identifying additional preventative measures.
- Identify, recommend, and implement improvements to routine functions.
- Provide SME support to Line Owners and NPI leads as needed.
Qualifications:
- Bachelor’s degree in life Sciences, Chemistry, or Engineering related fields
- Ability to adhere to current Good Manufacturing Practices cGMPs and follow Standard Operating Procedures SOPs.
- Understanding of typical unit operations for the manufacture of synthetic drug substance (i.e. weighing and dispensing, reactor charging, reactor and filter operations and other common unit operations) and for drug product (i.e. granulation, roller compaction, drying, milling, blending, compression, encapsulation and film coating)
- Strong technical skills to support problem solving exercises.
- PPE familiarity and ability to use a PAPR and breathing air suits.
- Ability to work with Microsoft Word, Excel, and PowerPoint
- Excellent verbal and written communication skills
- Strong interpersonal skills and a proactive leadership mindset
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
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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Quality Consulting Group