GMP MANUFACTURING TECHNICIAN I - Pace® Life Sciences : Job Details

About Us

Pace® Life Sciences

Pace® makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace® provides professional services to support their operations.

Job DescriptionThis is a full-time GMP Manufacturing Technician 1 position located in Norristown, PA, Monday - Friday, from 6:30 a.m. to 3:00 p.m. SUMMARY

Responsible for dispensing, manufacturing, and packaging operations in a Current Good Manufacturing Practice (cGMP) environment, while wearing appropriate PPE, maintaining accurate batch records and following all Standard Operating Procedures (SOPs). General, routine cleaning and maintenance of all equipment and instrumentation.

ESSENTIAL FUNCTIONS

• Assist with dispensing, manufacturing, and packaging of GMP clinical trial materials for clinical studies, while wearing appropriate PPE, as required.
• Complete manufacturing batch records in accordance with GMP documentation requirements.
• Perform assigned tasks in a clean room or sterile environment, including cleaning equipment, instrumentation and manufacturing suites.
• Maintain accurate records to support data integrity.
• Adhere to all SOPs, cGMP's and applicable FDA regulations.
• Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
• Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.

QUALIFICATIONS Education and Experience

• High School Diploma/GED required, some college or technical training preferred
• One (1) year of manufacturing operations or technical experience preferred; OR an equivalent combination of education, training and experience.

Required Knowledge and Skills Required Knowledge

• Prior knowledge preferred, or ability to be trained, in the use of drug product manufacturing equipment and instrumentation.
• Fundamental knowledge of practices, and techniques to troubleshoot and solve problems.
• Conscientious, follows directions, willing to learn.
• Fundamental understanding of working with batch records and documenting in laboratory notebooks preferred.
• Effective methods to communicate with staff, coworkers, and customers to ensure safe, effective and appropriate operations.
• Correct business English, including spelling, grammar, and punctuation.

Required Skills

• Ability to operate manufacturing equipment; while wearing appropriate PPE as required.
• Ability to follow standard operating procedures.
• Mechanical and math skills.
• Ability to operate in both a team and individual contributor environment.
• Fundamental understanding and following applicable laws, codes and regulations.
• Contributing effectively and taking initiative in accomplishing team or work unit goals, objectives, and activities.
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of work.

PHYSICAL/MENTAL REQUIREMENTS:

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

WORKING ENVIRONMENT:

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gasses, noxious odors, and related items in a lab setting.

Additional Information

Benefits

80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.

Equal Opportunity Employer

Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Work Schedule Monday through Friday, 6:30 AM - 3:00 PM