Specialist I, QC Method & Development

Location
Canton, MA, US
Posted
Sep 12, 2020
Ref
668036600
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

SPECIALIST I, QC METHOD & DEVELOPMENT

Emergent BioSolutions is currently seeking a Specialist I, QC Method and Development in our QC Department for our Canton location. The successful candidate will possess a Bachelor or Science degree in a scientific discipline with a minimum of 6 years computerized system administration within pharmaceutical manufacturing operations and knowledge of cGMP, FDA and Data Integrity (ALCOA) regulations. The ideal candidate will have proven experience supporting laboratory computerized systems and have excellent written and verbal communication skills. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

THE OPPORTUNITY

QC Specialist I will be responsible for administration of QC Systems in a compliant state throughout their lifecycle. Supports computerized systems for QC Department including Laboratories Information Management System (LIMS), Chromatographic Data System (Empower), Non-Chromatography Data Systems, and standalone computers. Responsible for monitoring and improving computerized systems performance by identifying, developing and implementing initiatives to enhance system administration, data integrity compliance, CSV activities, and system's incidents resolution. In addition, support with purchasing and qualifying new instruments for QC.

ESSENTIAL FUNCTIONS

  • Support the computerized systems for QC Department including Laboratories Information Management System (LIMS), Chromatographic Data System (Empower), Non-Chromatography Data Systems, Network, Communication Devices and standalone computers
  • Act as the Quality Computerized Systems SME for QC, support internal and external regulatory audits, and assure all systems are in compliance with required regulations
  • Manages the administration of QC computerized systems including user accounts configuration and maintenance, CSV documentation, system periodic review, audit trail review, computerized systems incidents evaluations and investigations, standard operating procedures for administration tasks, execution of backup/restore/achieve
  • Lead/ support data integrity assessments / remediation activities for new and existing computerized systems. Provide recommendation to remediate or mitigate findings, implement and validate modifications and assure the systems are maintained in compliance with regulatory requirements
  • Responsible for the development, execution, and/or review of CSV documentation for computerized systems and the execution of change controls as needed by QC.
  • Provides technical advice on the selection of equipment and system software for data acquisition and archival and other quality related systems.
  • Support analytical instrument qualification activities which may involve authoring URS (user requirement specifications), authoring qualification protocols and reports, executing instrument qualification protocols.
  • Author laboratory investigations, CAPA's and change controls.
  • Implement control systems to meet cGMP requirements where required including 21CFR Part 11 compliance.
  • Interact with corporate IT to ensure timely support for issues affecting QC systems.


EDUCATION, EXPERIENCE & SKILLS:

  • Bachelor of Science degree in a scientific discipline with a minimum of 6 years computerized system administration within pharmaceutical manufacturing operations
  • Knowledge of cGMP, FDA and Data Integrity (ALCOA) regulations is a must.
  • Experience computerized system validations methodologies, 21 CFR Part 11, and Data Integrity regulations.
  • Proven experience supporting laboratory computerized systems
  • Excellent written and verbal communication skills
  • Experience in authoring and executing instrument qualifications.
  • Experience with authoring Standard Operating Procedures (SOPs), change controls, deviations, and CAPAs.
  • Must be a team player and able to work cross-functionally in a matrixed environment


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
  • There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job.
  • This information is available upon request from the candidate.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.


Interested? Please visit Success Factors under the career section to apply today!

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .