Description
JOB SUMMARY
Responsible for performing various routine manufacturing tasks following established procedures and cGMP regulations under guidance of a production supervisor and/or senior management.
ESSENTIAL DUTIES & RESPONSIBILITIES
Follow production and manufacturing procedures.
Perform equipment preparation, bulk drug formulation, and aseptic filling duties as needed.
Accurately document data and complete batch records as needed.
Perform cleaning and sanitization duties as instructed by the applicable procedure.
Successfully complete facility's aseptic gowning and manufacturing qualification program.
Execute validation protocols as needed.
Train in various manufacturing tasks including, but not limited to: fill/finish, formulation, lyophilization, sanitization, component and equipment preparation, and finished product inspection and packaging activities.
Perform duties in ISO 4.8, ISO 6, ISO 7, and ISO 8 cleanrooms.
Perform routine maintenance of production equipment.
Assist in maintaining a warehouse that adheres to FDA regulations. This includes but is not limited to: hand truck and fork lift operation, sanitization, labeling, and staging.
Support Agency, customer and vendor audits as needed.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Perform all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
Ability to be detail-oriented.
Strong written and verbal communication skills.
Ability to work independently, within prescribed guidelines, or as a team member.
Familiar with Microsoft Office applications.
Proficiency in both written and verbal communication and presentations.
Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
Ability to work closely with a diverse customer base (internally and externally).
Ability to work well in a cross-functional team environment.
Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Requirements
EDUCATION, PRIOR EXPERIENCE, & TRAINING
Minimum of a high school diploma and zero to one (0-1) year relevant experience in manufacturing or a laboratory environment is required.
Bachelor's degree, or equivalent experience is preferred.
GRAM supports Equal Opportunity Employment
