Manufacturing Specialist

RXinsider LTD.; Cherry Hill Township (NJ); On-site; USD 65,000 - 95,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ is seeking a Manufacturing Specialist to support the Compounding department with a hands-on approach to production oversight.

The role involves filling, sterilization, equipment prep, and ensuring compliance with quality systems. The ideal candidate holds a technical BS or has 5 years in pharma injectables manufacturing as an alternative to a four-year degree, and will work to meet production budgets while advancing cGMP standards and training

Qualifications

• B.S. in a technical discipline or 5 years pharma injectables manufacturing as alternative to a 4 year degree.
• Experience with manufacturing processes and compliance.
• Knowledge of cGMPs and quality systems.

Responsibilities

• Oversee production activities including filling, sterilization, component and equipment prep, and compounding.
• Complete quality systems activities including commitments, deviations, DCEs, and SOP revisions as necessary.
• Meet budget, quality, and production goals, set standards, and make staffing recommendations.
• Interpret manufacturing policies, procedures, and programs.
• Qualify to work in and operate equipment in the assigned area.
• Assist the shift lead and Group Leader to ensure lines run efficiently and in compliance.
• Emphasize training and ensure training compliance.
• Support and emphasize Safety and Quality commitments.
• Analyze staffing needs.
• Drive operational excellence projects.

Skills

Hands-on

Quality systems

cGMPs

Communication

Teamwork

Production oversight

Education

Bachelor's degree in a technical discipline

Job description

Job Title: Manufacturing Specialist

Location: Cherry Hill, NJ

Job Type: Full-time

About Us:

We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Manufacturing Specialist for our Compounding department.

KEY RESPONSIBILITES

The Manufacturing Specialist will assist the shift lead in a hands-on approach to overseeing production activities including, filling, sterilization, component and equipment prep, and compounding. Completes quality systems activities including commitments, deviations, DCEs, and SOP revisions as necessary. Responsible for meeting budget, quality, and production goals, setting standards, and making employment and staffing recommendations. Interprets manufacturing policies, procedures, and programs

• Qualified to work in and operate equipment in the assigned area of responsibility (i.e., ability to be gown qualified).


• Assists the shift lead (supervisor) and Group Leader in ensuring production lines run efficiently and in a high state of compliance.


• Completes deviations, commitments, DCEs, and SOP revisions as necessary.


• Emphasize training and ensures training compliance.


• Support and emphasize the Safety and Quality commitments of the department.


• Analyze staffing needs.


• Responsible for driving operational excellence projects.


• Requires a B.S. in technical discipline with 0 to 3 years experience in manufacturing processes or 5 years experience in pharmaceutical injectables manufacturing as an alternative to a 4 year degree.


• Sound knowledge and understanding of cGMPs. Ability to manage multiple priorities and projects. Must work well as a member of a team. Good oral and written communication skills. Ability to communicate well—written and oral.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.