Specialist, QA

Employer
Celgene
Location
Warren, NJ
Posted
Jun 13, 2018
Ref
1801266
Required Education
Bachelors Degree
Position Type
Full time

Other Locations:US- NJ- Warren


Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

PURPOSE AND SCOPE OF POSITION

The Specialist, QA is responsible for quality and disposition activities in accordance with Celgene policies, standards, procedures and Global cGMP.  Functional responsibilities include performing incoming material release and product release, ensuring accurate and timely maintenance and review of manufacturing batch record documentation, providing operations shop floor oversight, and performing document issuance for manufacturing.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities

  • Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.

  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

  • Must possess an independent mindset.

  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.

  • Work is self-directed.

  • Confident in making decisions for non-routine issues.

  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.

  • Proposes solutions for complex issues and works with management to resolve.   Follows established procedures and performs work as assigned.

  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.

  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

  • Is recognized Subject Matter Expert within the group.

  • Provides guidance to other employees in interpretation of complex data.

  • Understands continuous improvement and improves efficiency and productivity within the group or project.

  • Builds relationships internally within and with cross functional teams.

  • Contributes to goals within the work group.

  • Able to recognize conflict and notify management with proposed recommendations for resolution.

  • Able to prepare written communications and communicate problems to management with clarity and accuracy.

  • Able to effectively multi-task.

  • Knowledge of US and global cGMP requirements.

  • Excellent verbal and written communication skills.

DUTIES AND RESPONSIBILITIES

  • Review and approval of executed batch records.

  • Responsible for disposition of incoming production materials.

  • Responsible for release activities for site manufactured drug product.

  • Provide oversight of QA shop floor program.

  • Issue production batch records and product labels to Operations.

  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

  • Must be skilled in planning and organizing, decision-making, and building relationships.

  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

  • Able to effectively multi-task.

EDUCATION AND EXPERIENCE

B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry. Equivalent combination of education and experience acceptable.

WORKING CONDITIONS

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.