What are the responsibilities and job description for the Manufacturing specialist position at Curia?
Curia Manufacturing Specialist Albuquerque, New Mexico
Manufacturing Specialist in Albuquerque, NM
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Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Manufacturing Specialist is the lead person for operations and manufacturing (i.e., vial prep, isolator, fill line operation, and vial sealing) of parenteral products according to Current Good Manufacturing Practice (cGMP) in an aseptic environment.
This role will train, coach / develop, and provide timely feedback to team members. Responsibilities encompass delivering production requirements, training operators to set up, operate, sanitize, and sterilize equipment and manufacturing areas in a cleanroom setting.
The Manufacturing Specialist ensures compliance with all relevant regulations and procedures, maintains current good documentation practices (cGDP) for all activities, and participates in training and continuous improvement initiatives to enhance production processes and efficiency.
Essential Duties and Responsibilities :
- Trains, coaches / develops, and provides timely feedback to team members.
- Represents Manufacturing in leadership meetings to support dedicated areas of responsibility.
- Revise SOPs and documents as needed.
- Drive activities and resolutions to improve process flow, safety, and overall production efficiency by identifying bottlenecks and fostering a culture of continuous improvement.
- Identify and resolve complex manufacturing issues through collaboration with quality, engineering, and technical operations management.
- Manage area of responsibility by ensuring compliance with cGMP standards, overseeing the proper operation and maintenance of equipment, and coordinating the sanitation and sterilization processes.
- Ensure compliance with Drug Enforcement Administration (DEA) regulations during controlled substance formulations and verify that staff adheres to these regulations.
- Ensure the timely processing and proper execution of deviations, assessments, investigations & CAPA’s.
- Manage the preparation and sterilization processes of equipment for clean rooms, product compounding, and filling according to the preparation list.
- Responsible for checking the recordings entered by employees of all procedures in logbooks as well as confirming complete / correct batch records according to cGDP.
- Oversee the staff to complete the sanitization of aseptic / controlled production areas.
- Escalate issues / concerns in a timely manner as appropriate to higher management.
- Cross-functional collaboration with all levels.
- Read / interpret SOPs to ensure compliance.
- Maintain up-to-date training.
- Other duties may be assigned.
Education and Experience :
Bachelor’s Degree in Mechanical Engineering, Biochemical Engineering, Chemical Engineering, or related discipline. Prior experience in a fill / finish GMP and / or cleanroom is preferred.
Language Skills :
The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations.
Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.
Computer Skills :
The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions.
Ability to cultivate a culture of continuous improvement and right first-time quality. Fosters a collaborative and positive work environment.
Promotes a safe and healthy work environment by actively identifying and addressing potential hazards.
Other Qualifications :
Must pass a background check and a drug screen. May be required to pass Occupational Health Screening. Must be able to obtain and maintain gowning certification, media qualification, and be able to wear a respirator.
Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Curia is an E-Verify employer.
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Last updated : 2024-10-15
