Quality Assurance Inspector

Work Schedule

Environmental Conditions

Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Reports to Allentown PA Site. CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time a concept that we internally embrace as There is a Patient Waiting. Our unique blend of services includes project management packaging distribution transportation management and specialty logistics ancillary supply management clinical supply optimization bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.

A Day in the Life:

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 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 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.

A Day in the Life:

• 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.
• Authors revises and follows all relevant SOPs/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 SOPs 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.

Benefits

We offer competitive remuneration annual incentive plan bonus scheme healthcare and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation.