Hours : Second shift, : - : , Monday-Friday. OT as needed

What will you do?

Our company seeks a Quality Assurance Inspector responsible for the quality of clinical products processed through primary and secondary packaging, warehouse, and distribution operations.

This role requires attention to details, the keen ability to Client defects and errors, ability to communicate both verbally and written, and collaborate with cross-functional groups in problem solving.

How will you get here?

Education

Associates degree or High School Diploma with years of experience.

Responsibilities

• Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
• Demonstrates and promotes the company vision.
• Performs approval of specifications and incoming inspections on material ( drug, components) and distribution shipments.
• Performs material and process inspections and samplings.
• Participates in continuous improvement initiatives and assists with root cause investigations for nonconforming issues.
• Author’s, revises, and complies with all relevant SOP’s and Work Instructions and properly documents activities when necessary.
• Resolve and assure that issues potentially affecting product quality / compliance are escalated to the attention of the Team Leader and / or Management.
• Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
• Performs all activities in a safe and efficient manner.
• Other duties may be assigned to meet business needs.

Knowledge, Skills, Abilities

• A minimum of year of experience in Pharmaceutical or of a related, regulated industry and a high school diploma.
• Familiar with Quality Systems (Change Control, deviations, complaint management, documentation management, among others).
• Must be able to work in a refrigerated environment (F to F) with provided protective wear.
• Must be able to work in a freezer (-F) environment with provided protective wear.
• Must be able to work in potent compound suites with provided protective wear (PPE).
• Good reasoning and problem-solving skills, basic math skills, good communication skills, basic computer skills.
• Must be willing to work various shifts and overtime depending on business needs.
• Must be able to work independently.
• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.

Physical Requirements

• Must not be allergic to penicillin or cephalosporin products.
• Extensive standing and walking on packaging floor in order to monitor room activities.
• Work schedule, Monday through Friday, hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
• This position requires standing, bending and lifting. Exerting and lifting up to lbs of materials occasionally, and lbs of materials regularly.
• The position is exposed to cold temperatures for more than one hour at a time.
• The position is exposed to -F temperatures for at least minutes at a time.
• The position will be exposed to atmospheric conditions could require special personal protection equipment.
• Incumbent must meet applicable visual acuity / color blindness standards to perform visual inspections in a cGMP environment

Comments for Suppliers :

EEO :