Team Leader, Quality Assurance

Work Schedule

Weekend days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Title: Team Leader, Quality Assurance

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.

Division/Site Specific Information

Role reports to the Allentown, PA site and reports to the Clinical Trials Division (CTD). 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 outstanding 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.

Schedule: Weekend work schedule (Friday, Saturday, Sunday). Overtime work may be required. (6am to 6:30pm/may need to arrive early/stay late to transition.)

Discover Impactful Work:
The Quality Assurance Team Leader will oversee the quality team and quality functions in relation to clinical packaging activities that include the clinical products processed through primary and secondary packaging operations. The role involves close interaction with relevant cross functional groups at the site.

A Day in the Life:

• The role requires the ability to problem solve and effectively ensure the site follows established quality systems. Additionally, the role requires the ability to communicate both verbally and written.
• Works with Area Manager to review significant aspects of operations related to quality.
• Ensure that issues are resolved in a timely manner and corrective actions are implemented accordingly.
• Participates in continuous improvement initiatives.
• Interacts with clients on quality issues, acting as an advocate on the company’s quality concepts.
• \Authors, revises, and complies with all relevant procedures and properly documents activities when necessary.
• Resolves and assures that issues potentially affecting product quality/compliance are escalated to management.
• Conducts all activities in a safe and effective manner.
• Other duties maybe be assigned to meet business needs.

Keys to Success:

Education/Education

• Bachelor’s degree, preferably with a technical or life sciences focus highly preferred.
• High school diploma, or equivalent required.
• A minimum of 3 years with BS degree, or 5 years of experience in Pharmaceutical or related, regulated industry required.
• Experience in a leadership role.
• Experience with Quality Systems (e.g., Change Control, deviations, complaint management, and documentation management).
• Experience with risk assessment and root cause analysis.
• Lead and develop teams while fostering a quality-focused culture.

Knowledge, Skills, Abilities

• Strong knowledge of cGMP, FDA regulations, ICH guidelines and quality systems.
• Demonstrates and promotes the company vision.
• Ability to perform as a working manager, performing Quality Inspector functions daily.
• Strong technical writing skills for SOP’s, investigations, and regulatory documentation.
• Strong interpersonal skills and communication abilities to interact with all levels of the organization.
• Excellent verbal and written communication and be able to communicate effectively.
• Must have good working knowledge of cGMP Regulations
• Must be able to work independently.
• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP
• Must be skilled in decision-making, building relationships, problem solving, planning and organizing.

Physical Requirements:

• Extensive standing and walking on packaging floor in order to monitor room activities.
• This position requires standing, bending and lifting. Exerting and lifting up 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.

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