Under limited supervision and guidance of the QA Supervisor is responsible for the following duties:
Include the following. Other duties may be assigned.
· Inspection and evaluation of incoming packaging and labeling components.
· Raw material sampling and assessment.
· Perform Line Clearances.
· Physical evaluation of drug products such as but not limited to: Torque test, leakage, fill weight, etc).
· In-process inspection of drug products during filling and packaging operation for correct product strength, lot, expiration date, etc.
· Collecting and testing cleaning samples and assisting with cleaning validations.
· Recording room pressure and temperature data (aseptic core).
· Monitoring purified water system for temperature, pressure, resistivity, etc.
· Verifying the raw materials/ incoming components are in the right status in JDE and physical location
· Perform Shop Floor QA activities.
· Provide Shift Change reports.
· Review of Batch Records and any Ancillary GXP documents executed during Production.
· Successfully meet aseptic gowning qualifications.
· Support stability sampling program for finished product.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:
A minimum of a High School Diploma or GED and a minimum of 1 year of job related experience
· Basic knowledge of cGMP.
· Basic knowledge of chemistry / microbiology / biology
· Familiarity with USP/NF (US Pharmacopea/National Formulary).
· Math Skills (addition, subtraction, multiplication, division, etc.)
· Verbal communication and writing skills.
· Well organized. Ability to meet attendance standards. All full-time employees are required to work a 40 hour week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use. Additional physical requirements include the ability to hear accurately the spoken word with moderate office noise (or plant noise).
Mental requirements include:
v Ability to apply deductive reasoning and understand complicated issues
v Ability to receive instructions and follow work rules and company policies
v Ability to follow safety and security practices
v Ability to meet deadlines and effectively deal with office stress
v Ability to accurately communicate ideas, facts and technical information
v Maintain confidentiality of certain information