Lead QC Technician

Regulatory Toolkit; Allentown (Lehigh County); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Healthcare

Bonus plan

Company benefits

Job summary

Thermo Fisher Scientific is seeking an Operations, Clinical Quality Assurance Inspector to support packaging activities of clinical products and some commercial packaging. The role requires strong communication skills, familiarity with cGMP, and collaboration with cross-functional teams at the Allentown site.

Responsibilities include ensuring compliance with quality systems, reviewing specifications, and performing inspections, with potential overtime and weekend work based on business needs.

Qualifications

• Associates degree preferred or High School Diploma required.
• At least 2 years of experience in Pharmaceutical or related regulated industry.
• Experience with Quality Systems (Change Control, Deviations, Complaint Management, Documentation Management, among others).
• Must be willing to work in refrigerated and freezer environments with provided PPE.
• Ability to work shifts and overtime depending on business needs.

Responsibilities

• Apply Good Manufacturing Practices (cGMP) in all areas of responsibility.
• Demonstrates and promotes the company vision.
• Performs approval of specifications and Incoming Inspections on material 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.
• Documents activities accurately and follows SOPs/Work Instructions.
• Raises issues potentially affecting product quality to Team Leader/Management.
• Ensures timely resolution and implementation of corrective actions.
• Performs all activities in a safe and efficient manner.
• Other duties may be assigned to meet business needs.

Skills

Quality Systems

cGMP

SOPs

Documentation

Independent work

Education

Associates degree preferred

High School Diploma or equivalent

Job description

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Work Schedule: Standard Mon – Fri 2nd shift 3:15 pm – 11:15 pm (possibly OT)

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.)

DESCRIPTION:

As part of the Thermo Fisher Scientific team, you'll 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.

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 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 operations. Support for 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 solve problems and effectively ensure the site follows established quality systems. Additionally, the role requires strong communication skills both verbally and written. Candidates should have experience with cGMP regulations.

A Day in Life

• Apply 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 affect 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.

REQUIREMENTS

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 and could require special personal protection equipment.
• Position is responsible for inspection of pharmaceutical products, components, and labels. Incumbents 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.