Senior Quality Specialist

2 weeks ago

Horsham PA United States Endo Full time

Why Endo?


We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.



Member of the Quality group providing support for all aspects of Development, Phase I-IV clinical, scale-up activities and commercial manufacturing, testing and release, as applicable. Supports internal and external quality operations and systems, such as facility/equipment, utilities, materials, production, laboratory, packaging/labeling, and general compliance as applicable. Assures compliance with current domestic and international GMPs and regulatory agencies. This role contributes to and may lead operational teams in the development, management, harmonization, and improvement of quality systems and procedures. The Senior Quality Specialist will assist in decision making that requires developing options to solve moderate to complex issues.



Job Description



Scope: Horsham, PA internal manufacturing sites (all Horsham based GMP functions/departments; Quality oversight for implementation of all electronic Quality Systems and Manufacturing Site IT Systems , including manufacturing, labs, building management systems, etc.).


Responsible for working with Endo departments and suppliers to identify and correct issues; Assures that Endo complies with company procedures as well as Health Authority regulations.


Works with all levels of management and suppliers to accomplish all regulatory compliance objectives.


Trains junior QA team members.


Batch Record/Reports Review

  • Supports the QA batch release functions for cGMP commercial, clinical, and development manufacturing and distribution activities from the local, contract manufacturing, filling, and packaging facilities.

Quality Documentation/Reports Review

  • Contributes to preparation and/or review of annual product review and updates for regulatory filing(s), batch release metrics, and department reporting as applicable.
  • Releases consumables and raw materials used in the manufacturing process and drug substances/drug product.
  • Assists with decisions that require developing options to solve moderate to complex issues.

Quality Documentation

  • Prepares and/or reviews controlled documents (e.g. SOPs) required for compliance.

Quality Systems & CAPA Investigations

  • Contributes to and may lead operational teams in the development, management, harmonization, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and company quality standards in support of cGxP activities.
  • Assists with all aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events.

Quality Documentation

  • Contributes to preparation and/or review of annual product review and updates for regulatory filing(s), batch release metrics, and department reporting as applicable.
  • Supports implementation and/or recommends internal/external business or compliance options and best practices to improve products, processes or services.

Inspection Readiness

  • Participates in cross functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities and special projects.



Qualifications

Education & Experience

  • Associate’s degree in science or engineering with 7+ years’ experience in pharmaceutical / biopharmaceutical industry OR
  • Bachelor’s degree in above fields with 5+ years’ experience in pharmaceutical / biopharmaceutical industry OR
  • Master’s degree in above fields with 3+ years’ experience in pharmaceutical / biopharmaceutical industry OR
  • PhD in above fields with 1+ years’ experience in pharmaceutical / biopharmaceutical industry.
  • Industry experience with aseptic operations, CMO, CTL and packaging/labeling required.


Knowledge

  • Strong knowledge of the principles, concepts and theories of the compliance/QA discipline.
  • Advanced knowledge in QA discipline(s) (e.g., Change Control, Investigation, etc.).
  • Deep understanding and knowledge of cGMP regulations.

Skills & Abilities

  • Strong verbal and communication skills required.
  • Attention to detail required.
  • Demonstrated excellent interpersonal skills and flexibility.
  • Ability to handle multiple priorities in a fast-paced environment.
  • Good writing skills.
  • Strong organizational skills.
  • Ability to build peer relationships.


Physical Requirements

  • Routine office work (walk/sit/stand); no travel requirements.



Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.


EEO Statement:

At Endo we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

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