Supervisor, QA

Employer
Celgene
Location
Phoenix, AZ
Posted
Jul 10, 2018
Ref
1801458
Required Education
High School or equivalent
Position Type
Full time

Other Locations:US- AZ- Phoenix


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 Supervisor, QA carries out supervisory responsibilities in accordance with the organization's

policies, procedures, Good Manufacturing Practices and state, federal, and local laws. Under

general supervision, coordinates and directs the quality assurance functions ensuring the safety,

quality, potency and purity of injectable pharmaceutical products. The Supervisor, QA will ensure

compliance with global cGMP's and applicable department programs, including training,

documentation, standard operating procedures, and policies.

Required Competencies: Knowledge, Skills, and Abilities

 Intermediate knowledge of cGMP, OSHA, USP and EP

 Ability to critically assess project(s) and allocate resources to efficiently achieve goals

 Requires flexibility and ability to multi-task

 Advanced teamwork and facilitation skills

 Advanced critical reasoning and decision making skills

 Able to more fully interpret results and situations and articulate recommendations for resolution

 Ability to recognize risk and develop contingency plans. Requires ability to develop others,

delegate and motivate

 Basic knowledge of continuous improvement and improves efficiency and productivity within the

group or project

 Ability to provide guidance to other employees in interpretation of complex data

 Able to provide input and build relationships internally within function and with cross-functional

teams

 Able to implement solutions independently

 Able to write and review reports with clarity and brevity and provides guidance to other

employees in technical writing skills

 Able to prepare written communications and communicate problems to management with clarity

and accuracy

Duties and Responsibilities

Oversees, supervises, coordinates and prioritizes the daily activities of Quality Assurance personnel.

 Assures appropriateness of procedures, protocols and risk management to maintain site

compliance and product quality.

 Performs review and disposition of process/product deviation investigation reports, ensuring

all deviations are thoroughly investigated, documented, and that proper corrective action is

taken.

 Performs Quality Operations review/approval of Standard Operating Procedures (SOP),

Document Change Requests (DCR), Change Controls, and Work Orders.

Ensures site and global project deadlines and performance standards are established and met.

 Interfaces with all other quality groups within the company on quality systems issues.

 Works with Plant Operations to ensure compliance with and understanding of cGMPs,

SOPs, and policies.

 Assists with FDA and other regulatory agency audits and inspections.

Oversees, participates and approves the interviewing, hiring and training of departmental employees;

and conducts performance evaluation for direct reports.

 Participates in the department budget process and operates within established budget.

 Provides support, direction and coaching to subordinate employees in the areas of training,

disciplinary action, problem solving, planning and work assignment delegation.

Performs all other tasks as assigned

Education and Experience

 High school diploma or equivalent required.

 Bachelor's degree preferred.

 4 years' relevant work experience required, preferably in a pharmaceutical environment.

 1 year of leadership and/or team development experience preferred.

 An equivalent combination of education, experience and training may substitute.

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.

This job description is intended to describe the general nature and level of work being performed by the

person assigned to this position. The primary duties and responsibilities are intended to describe those

functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities

assigned to this position. There are other duties and responsibilities that are considered incidental or

secondary to the overall purpose of this job. Employees holding this position will be required to perform

any other job-related duties as requested by management.

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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.