PURPOSE OF JOB ROLE:
The primary responsibility is to support the qualification of analytical instruments across GMS Rockville manufacturing and laboratory areas. Assure the analytical instrument validation program is compliant with global, site and industry practices.
KEY RESPONSIBILITIES: (10 bullet points maximum)
Supports analytical instrument qualifications and projects by writing and executing validation protocols ensuring compliance with cGMPs.
Authors final reports summarizing execution of analytical instrument qualification protocols and support documents (amendments, repeat test forms, addenda and deviations) in support of analytical instrument qualifications.
Interface with Validation, Laboratory Services and System Owners to facilitate timely protocol execution and remediate issues during protocol execution.
Interface with regulatory authorities and partners as the SME for the analytical instrument validation program.
Participate in the administration of the analytical instrument validation program.
Schedule and coordinate analytical instrument validation activities with vendors and system owners.
Participate in change control reviews and updates of validated analytical instruments.
Responsible for continuous improvement of the analytical instrument validation program.
Responsible for participating in the quarterly Analytical Instrument Working Group meeting.
Trained in self inspections and participate in ~25% of department's self Inspections.
Why You?Basic qualifications:
BS/BA in science degree or equivalent technical discipline
Science degree with a minimum of 3 years' experience in biopharmaceutical or pharmaceutical field
Familiar with the operation and qualification of analytical instruments used within biopharmaceutical manufacturing and QC labs
Understanding of the requirements of a Biopharma/regulated environment
Able to communicate effectively with cross-functional teams of diverse people
Strong planning and program management skills
Effective organization, communication, presentation and influencing skills.
Exposure to SAP, QUMAS eDocCompliance, Quality Center ALM,
Familiarity with electronic Data Integrity requirements
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.