Job Information
Actalent GMP Visual Inspection in Cockeysville, Maryland
Job Title: GMP Visual Inspection
Job Description
Responsible for the mechanical setup, operation, control, monitoring and cleaning of various equipment to inspect & package sterile injectables while following Standard Operating Procedures (SOPs). Will be 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, as well as Commercial manufacturing of various pharmaceutical products with cGMPs per the manufacturing schedule.
Maintain visual inspection documents and consistently check all documents for errors, constantly striving for right-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
Ability to read, write, and perform basic math calculations (addition, subtraction, multiplication, and division).
Comprehend and follow verbal and written instructions, such as cGMP’s, SOP’s, Batch Records, policies, procedures, etc.
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 sound compliance understanding.
Additional Skills & Qualifications
Experience with contract manufacturing, inspection, quality assurance.
Knowledge of sterile injectables, aseptic techniques, document control, compliance, quality control, and cleanroom environments.
Work Environment
Will be working in a class 100 manufacturing cleanroom. A class 100 cleanroom maintains less than one hundred particles larger than 0.5 microns in each cubic foot of air space. It is equivalent to 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.