GMP Visual Inspection Job at Actalent in Cockeysville
Actalent, Cockeysville, MD, United States, 21030
Job Title: GMP Visual Inspection
Job Description
Responsible for the mechanical setup, operation, control, monitoring, and cleaning of various equipment to inspect and package sterile injectables while following Standard Operating Procedures (SOPs). The role requires working in an aseptically clean environment to minimize microbial contamination.
Responsibilities
+ Assist in various manufacturing activities related to visual inspection as needed.
+ Setup, operation, and cleaning of various manufacturing equipment and machines.
+ Successfully complete visual inspection for CTM batches, submission batches, PV batches, and commercial manufacturing of various pharmaceutical products with cGMPs per the manufacturing schedule.
+ Maintain visual inspection documents, consistently checking all documents for errors and striving for right the first-time mentality.
+ Observe safety and security procedures and meet department safety objectives.
+ Perform visual inspection of liquid and lyophilized vials and liquid syringes using manual inspection booths and/or semi-auto machines.
+ Assist with routine product sampling (i.e., AQL) as well as non-routine sampling for various engineering and validation studies.
Essential Skills
+ Experience within a GMP facility.
+ Ability to read, write, and perform basic math calculations (addition, subtraction, multiplication, and division).
+ Comprehend and follow verbal and written instructions such as cGMPs, SOPs, Batch Records, policies, and procedures.
+ Knowledge of current federal, local, and international regulations regarding the production of drug substances and products.
+ Good understanding of cGMPs, industry, and regulatory standards and guidelines.
+ Good understanding of federal and local regulations regarding health and safety within a manufacturing environment.
+ Proficiency with math, the metric system, weight, and volume measures.
+ Strong ethical foundation and a sound compliance understanding.
Additional Skills & Qualifications
+ Experience in contract manufacturing, inspection, quality assurance, and sterile injectables.
+ Knowledge in aseptic techniques and document control.
+ Compliance and quality control experience.
Work Environment
Will be working in a class 100 manufacturing cleanroom, which maintains less than one hundred particles larger than 0.5 microns in each cubic foot of air space. It is equivalent to an ISO class 5 cleanroom.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.