Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Scientist, QC Tech Services

Expired Job

Celgene Corporation Phoenix , AZ 85002

Posted 4 months ago

Scientist, QC Tech Services

Req #: 1801871

Location: Phoenix, AZUS

Job Category: Quality

Work Location: 620 N. 51st Avenue PHOENIX 85043

Organization: Abraxis Bioscience

Schedule: 40

Shift:

Employee Status: Full time

Job Type: Regular

Job Level:

Travel:

Other Locations:US- AZ- Phoenix

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.

Purpose and Scope of Position

The Scientist is responsible for supporting Quality Control analytical testing for release of products.

The Scientist is responsible for validating and transferring methods into the QC laboratory,

optimizing and troubleshooting methods; assisting in teaching and training junior analysts.

Required Competencies: Knowledge, Skills, and Abilities

Hands on experience with various analytical techniques and scientific knowledge in the

characterization of pharmaceutical drug products.

Intermediate ability to accurately and completely understand, follow, interpret and apply

Global Regulatory and cGMP requirements.

Ability to interact with regulatory auditors as Subject Matter Expert (SME).

Intermediate technical writing skills.

Strong problem solving ability/mentality, technically adept and logical.

Intermediate organizational and time management skills.

Intermediate knowledge of laboratory instrumentation.

Demonstrated ability to communicate effectively with peers, department management and

cross-functional peers.

Duties and Responsibilities

Independently manages projects

With assistance, designs and executes experiments, analyzes results, and writes technical

summary reports.

Capable of handling moderate issues and solving problems.

Prepare and present continuous improvement projects to management.

Utilize scientific principles to assist in analytical testing methods and the proper use of

laboratory instrumentation.

Broad understanding of ICH Guidelines and can independently develop, write and execute

method Verification/transfer /validation protocols/Reports and related activities.

Assist management with investigations and deviations.

Integrate enterprise systems into the Laboratory

Assist in implementing electronic data capture software into the QC laboratory

Assist in writing appropriate interface templates to capture data results with only general

guidance

Assist with writing custom calculations to produce data results

Assist with peer review and verification of data

Serve as technical reviewer of appropriate departmental procedures

Review documentation as required by laboratory procedures

Perform verification of software templates and custom fields

Perform peer review as needed for QC Technical Services Projects

Performs other tasks as assigned

Education and Experience

High school diploma or equivalent required.

Bachelor Degree preferred, preferable in Science.
4 years relevant work experience required, preferable in a regulated environment.

An equivalent combination of education and experience may substitute.

Working Conditions

The incumbent will be required to stand for extended periods of time, up to 6 hours per day

This position requires regular medical surveillance and may require incumbent to wear a

respirator or gown.

The incumbent must be able to distinguish colors and possess correctable vision to 20/20,

annual eye exam is required.

The incumbent must analyze numerical values on a daily basis.

The incumbent will be working a laboratory setting up to 6 hours per day.

The incumbent will occasionally be working around hazardous materials to include chemical

agents up to 6 hours per day.

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.

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.



See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Director QC

Celgene Corporation

Posted 1 week ago

VIEW JOBS 12/3/2018 12:00:00 AM 2019-03-03T00:00 Director, QC Req #: 1802966 Location: Phoenix, AZUS Job Category: Quality Work Location: 620 N. 51st Avenue PHOENIX 85043 Organization: Abraxis Bioscience Schedule: 40 Shift: Employee Status: Full time Job Type: Regular Job Level: Travel: Other Locations:US- AZ- Phoenix 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. DIRECTOR, QCPhoenix, AZ 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 Director, QC is responsible for directing all operational aspects of the Quality Control Laboratories, including QC Chemistry, QC Microbiology, QC Systems and Services, and QC Incoming in support of drug manufacturing, testing and development. Required Competencies: Knowledge, Skills, and Abilities * Advanced knowledge of global pharmaceutical regulatory requirements and their impact to commercial laboratory operations including but not limited to FDA, EU, PMDA, OSHA, DEA * Advanced knowledge of technical purpose and capability of laboratory instrumentation, software and techniques * Ability to interpret/write general, technical, and complex business documents * Advanced presentation development and delivery skills * Advanced time management and organizational skills * Advanced critical reasoning, strategic thinking and decision-making skills * Advanced team and facilitation skills * Ability to deal effectively with regulatory agencies * Ability to be flexible and multi-task * Advanced written and verbal communication skills * Ability to work independently for extended periods of time * Ability to develop others, delegate and motivate * Ability to effectively collaborate cross-functionally to drive effective communication * Strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility and tolerance Duties and Responsibilities Lead site Quality Control Chemistry department * Direct all functional accountabilities for the Quality Control Laboratories in accordance with organization's policies and procedures. * Set strategic vision for the department which aligns with both internal and global priorities. * Ensure raw material, bulk, product release and stability testing activities are conducted in a timely manner. * Ensure timely availability, reliability and accuracy of the test data. * Provide analytical expertise and guidance for analytical method development & validation activities and support development projects in a timely manner. * Oversee the investigation of quality control related problems in raw materials, in-process and finished products in order to develop appropriate corrective and preventive actions and to recommend disposition of products. * Participate in production planning process, prepare budgets, recommend capital expenditures for technology and equipment, and allocate human resources to support manufacturing, testing, and investigations. * Ensure that review and approval of laboratory data and investigations is performed accordance with cGMP's and good documentation practices. * Ensure that laboratory analyses and investigations performed by contract laboratories or contract employees is performed accordance with cGMP's and good documentation practices. * Support review and approval of new and revised QC related SOP's ensuring compliance with cGMP's. * Support technical review of pharmacopeia (USP, EP, BP, JP) and Supplements to ensure methodology and procedures are compliant with current standards. Provide support for emerging topics published by each of the pharmacopeia. * Participate in audits conducted by regulatory agency representatives. * Oversee all aspects of the department including incoming, chemistry, microbiology, systems and services group activities. * Coordinate between site stakeholders and laboratory management to ensure routine activities of department support requirements for commercial manufacture and release of product. * Collaborate with site management to ensure appropriate departmental support as priorities change employing principles of change management. Foster a well-trained, motivated and informed staff * Ensure all department staff receive training in applicable cGMP's SOP's, Company Policies and safety, and that employees meet defined qualification requirements for the position to which they are assigned. * Mentor department management staff. * Conduct department meetings. * Drive sense of team responsibility for group's success. * Work closely with Human Resources on Policy changes, interpretation and execution; Hiring of new employees, Employee disciplinary action, Performance Appraisals and Personnel Development. * Performs other tasks as assigned Education and Experience * Bachelor's degree required, preferably in Chemistry, Microbiology, or related science * 12 years' relevant work experience required * 5 years of leadership experience with direct reports required * An equivalent combination of education and experience may substitute Working Conditions * The incumbent will be required to work in an office environment potentially requiring ergonomic considerations * The incumbent will be required to work in a conference room environment for moderate periods of time. * Brief exposure to labs, production or warehouse environments 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. #LI-POST 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. Celgene Corporation Phoenix AZ

Scientist, QC Tech Services

Expired Job

Celgene Corporation