Quality Assurance Inspector 3rd shift

Regulatory Jobs; Allentown (Lehigh County); On-site; USD 65,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Lead QC Technician to ensure quality standards in a cGMP environment and to support packaging activities for clinical and commercial products. The role involves working with the Operations and Quality teams, problem-solving, and maintaining compliance through documentation and SOPs.

The position requires experience in regulated industries, ability to work 3rd shift, and willingness to adapt to overtime and varying schedules to meet business needs.

Qualifications

• Associates degree preferred.
• High School Diploma or equivalent required.
• At least 2 years of experience in Pharmaceutical or related regulated industry.
• Familiar with Quality Systems (Change Control, Deviations, Documentation Management).
• Must work in refrigerated and freezer environments with provided PPE.

Responsibilities

• Ensure quality standards in a cGMP environment through product inspections and packaging activities.
• Support packaging operations for clinical and commercial products.
• Assist in deviation investigations, change controls and documentation management.
• Collaborate with cross-functional teams to ensure compliance and timely issue resolution.
• Maintain safety and GMP compliance in all activities.

Skills

cGMP knowledge

Quality Systems

Documentation

SOP compliance

Education

Associates degree preferred

High School Diploma

Job description

Work Schedule

Third Shift (Nights)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION

Join our team at Thermo Fisher Scientific as a Lead QC Technician, where youll help make the world healthier, cleaner and safer. In this important role, youll ensure quality standards are met through inspection of products in a cGMP environment.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 roleinvolves 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 andeffectively 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

REQUIREMENTS

• 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.

Keys to Success

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.