Quality Assurance Manager

Thermo Fisher
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Job Details

  • Location: Allentown, PA, 18103
  • Date Posted: 1 month ago
  • Employment Type: Full Time
  • Category: Manufacturing/Production
  • Req Number: 205630BR
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Description

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.

Discover Impactful Work

As part of our team, what you do contributes directly to our Mission: to enable our customers to make the world healthier, cleaner, and safer.

What will you do?

The Quality Assurance Manager will coordinate all Quality functions in relation to Supply Chain and management of a team of QA Inspectors. Oversight of the team responsible for incoming inspection of components, drug product, and labels. This position will also oversee distribution and sampling activities, inclusive of the general state and GMP compliance of all warehouse and sampling areas.

How will you get there?

  • Bachelor’s Degree is required
  • 4 years of experience in Pharmaceutical or of a related, regulated industry
  • 2 years of supervisory experience or equivalent required

Responsibilities

  • Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
  • Demonstrates and promotes the company vision.
  • Establishes procedures for maintaining quality standards.
  • Provides leadership in promoting and implementing company quality requirements.
  • Evaluates and develops techniques crafted to maintain awareness of SOP’s, current GxP's and clinical requirements.
  • Develops and leads Quality Assurance systems that will improve and maintain products that meet quality specifications and standards.
  • Optimally leads QA training sessions for CGP’s, SOP’s, company requirements, etc.
  • Extensively interacts with Operations and Distribution Managers to resolve quality issues.
  • Works with QA Area Manager to periodically review significant aspects of operations related to quality.
  • Guide and assist personnel to proficiency on inspection procedures and techniques.
  • Provides positive and critical feedback to employees relative to job performance.
  • Completes the regular performance evaluation of QA Supply Chain Team including the identification of development needs.
  • Raises issues to the attention of Senior Leadership that could potentially affect product quality/compliance.
  • Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
  • Acts as Quality Sponsor and interacts with clients on quality issues, acting as an advocate on the company’s quality concepts.
  • Conducts all activities in a safe and efficient manner.

Knowledge, Skills, Abilities

  • Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, among others), people management
  • Experience mentoring and creating development opportunities for staff
  • Must have strong project management, statistical analysis, and interpersonal skills
  • Must have good understanding of cGMP Regulations
  • Organizational skills are required to quickly retrieve needed documents
  • Experience collaborating with Regulatory bodies - FDA/EU/Health Canada/MPA
  • Must be comfortable with decision-making on diversified issues and interacting with customers on a routine basis.
  • Proficiency in skills required to read, understand, and adhere to the SOPs and policies of a GMP environment
  • Management of personnel in a cGMP environment

Physical Requirements

  • This role is positioned in a warehouse/packaging environment and requires standing, bending, reaching, walking and talking as well as exerting up to 25lbs of force occasionally.
  • Position coordinates with personnel working in cold/frozen temperatures for short durations, as well as personnel working in potent compound suites using provided protective wear (PPE).
  • Must not be allergic to penicillin or cephalosporin products.
  • Incumbent must meet applicable visual acuity/color blindness standards to perform visual inspections of pharmaceutical products, components, and labels in a cGMP environment.
  • Work schedule is Monday through Friday.

At Thermo Fisher Scientific, each one of our 67,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

This is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be a comprehensive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.