Quality Assurance Inspector 3rd shift

Description

The Operations, Clinical Quality Assurance Inspector will support all Quality functions in relation to packaging activities of clinical product processed through primary and secondary packaging operations. Support of commercial packaging activities is also included. The role involves supporting management and the quality team and close interaction with relevant cross functional groups at the site. The role requires the ability to problem solve and effectively ensure the site follows established quality systems. Additionally, the role requires strong communication skills both verbally and written. Candidate should have experience with cGMP regulations.

Shift

3rd shift Sunday 11PM - Friday morning 7AM

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 (i.e. drug, components) and distribution shipments.
• Performs material and process inspections and samplings.
• Review and approve Packaging Electronic Production Orders.
• Participates in continuous improvement initiatives and assists with root cause investigations for nonconforming issues.
• Author's, revises and follows all relevant SOP's/Work Instructions and accurately documents activities as needed.
• Resolve and assure that issues potentially affecting product quality/compliance are raised 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.

Education

• Associates degree preferred.
• High School Diploma, or equivalent required.

Experience

• At least 2 years of experience in Pharmaceutical, or related regulated industry.

Knowledge, Skills, Abilities

• A minimum of 1 year of experience in Pharmaceutical or in a related, regulated industry and a High School diploma.
• Familiar with Quality Systems (Change Control, Deviations, Complaint Management, Documentation Management, among others).
• This job requires the incumbent to work in a refrigerated environment (2° C to 8° C) and freezer environment (-20° C) with provided protective wear.
• Must be willing to work various shifts and overtime depending on business needs.
• Ability to work independently.
• Skills required; to read, understand, and follow the SOP's, Work Instructions and policies of a GMP environment.

Physical Requirements

• Extensive standing and walking on packaging floor in order to monitor room activities.
• Work schedule, Monday through Friday, 8 hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
• This position requires standing, bending and lifting. Exerting and lifting to 25lbs of materials occasionally, and 10lbs of materials regularly.
• The position is exposed to cold temperatures for more than one hour at a time.
• The position is exposed to -20F temperatures for at least 15 minutes at a time.
• The position will be exposed to atmospheric conditions could require special personal protection equipment.
• Position is responsible for inspection of pharmaceutical products, components, and labels. Incumbent must meet applicable visual acuity/color blindness standards to perform visual inspections in a cGMP environment.