Specialist, QA Compliance

Employer
Celgene
Location
Warren, NJ, US
Posted
Sep 11, 2018
Ref
1803072
Required Education
Bachelors Degree
Position Type
Full time
Other Locations:US- NJ- Warren

Description

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.

Specialist, QA Compliance
Warren, NJ

Manager

Manager, QA Compliance

Prerequisites (As Applicable)

B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry.

PURPOSE AND SCOPE OF POSITION:

The Specialist is responsible for supporting the compliance group from a Subject Matter Expert (SME) standpoint in accordance with Celgene policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include performing approvals for manufacturing investigations, driving proactive and corrective improvements within Operations, managing the internal inspection readiness program, tracking internal/external audit commitments and driving on time closure, evaluation of new requirements and emerging regulations, and oversight for trending of quality compliance metrics.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

  • Must have experience with cGMP manufacturing, Quality, and compliance.
  • Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
  • Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • 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 minor issues.
  • Routinely recognizes Quality issues and solves problems.
  • 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.
  • Is recognized Subject Matter Expert within the group.
  • Provides guidance to other employees in interpretation of complex data.
  • Capable of providing input within the department and cross functional teams.
  • 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 write and review reports with clarity and brevity.
  • Able to effectively multi-task and execute project management skills.
  • Knowledge of US and global cGMP requirements.
  • Understanding of aseptic manufacturing processes.
  • Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
  • Ability to make independent and objective decisions and to work with minimal supervision.
  • Excellent verbal and written communication skills.


DUTIES AND RESPONSIBILITIES

  • Review and approve manufacturing deviation records associated with the clinical manufacturing process(es).
  • Provide QA input/path forward for potential manufacturing issues that occur on the shop floor.
  • Determine if a deviation record is required as per procedures.
  • Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
  • Ensure control of systems, processes and product through supporting review and approval of change notices and change control.
  • Responsible for scheduling and execution of the site internal auditing program assuring CAPAs are completed in a timely manner.
  • Monitor and track external audit commitments to ensure timely closure.
  • Review site change controls and ensure appropriate requirements are identified and completed for implementation.
  • Assess global standards/policies and emerging regulations.
  • Responsible for issuing site metrics for compliance and adherence to global requirements.


EDUCATION AND EXPERIENCE (As Applicable)

B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry.

WORKING CONDITIONS: (US Only)

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.