Principal Specialist, Validation & Lab Oversight
Posted on Dec 11, 2018 by Celgene
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.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have GMP, Quality, and in-depth risk management knowledge.
- Must be able to recognize and group technical/scientific attributes and drive science based decisions in most technical areas and to a deeper level in the specific job function.
- Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
- Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
- Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
- Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams
- Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
- Able to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
- Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.
- 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.
- Consults management for advice on complex issues.
- Work is self-directed.
- Is recognized Subject Matter Expert within the group.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
- Understands fundamental scientific problems.
- Able to write and review reports with clarity and brevity.
- Able to produce data reports with precision.
- Supports all activities for the Quality Operations Validation & Lab Oversight group.
- Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
- Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.
- Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
- Review media simulation activities to ensure successful execution and documentation.
- Ensure site is compliant with global and regulatory data governance and data integrity requirements.
- Establishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.
- Provide Quality oversight of QC Chemistry and QC Microbiology.
- Work with laboratory management to ensure laboratory activities comply with global regulatory requirements.
- Ensure procedures are adequate to review and confirm appropriateness of laboratory raw data.
- Review/approval of laboratory deviations.
- Ensure the site stability program meets global and regulatory requirements.
- Ensure method qualifications, method transfers, and analyst trainings meet company and regulatory requirements.
B.S. degree required, minimum of seven 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.
DEFINITIONS AND ABBREVIATIONS (As Applicable)
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.
Associated topics: antibody, aseptic, drug discovery, histotechnologist, immunohematology, kinesiology, medical, pharmaceutical, pharmacology, protein