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Kelly Services Quality Assurance / Document Control Specialist in Long Island City, New York

Quality Assurance Specialist

Long Island City, NY

Direct hire opportunity

Normal business hours with flex. 7-4, 8-5 M-F

Pay: based on education/experience

Job Description

The Quality Assurance Specialist develops, establishes and maintains Document Control methodologies, systems and practices which meet the applicable regulatory requirements and procedures. Serves as a Quality representative to improve Document Control, Training, Investigations and Good Documentation Practices awareness of the regulatory and requirements to the different functional areas. Provides Document Control, Training support to the Quality and R&D teams, as needed.

Administers any applicable company investigation into the GXP system for Change Controls, CAPA, QC Laboratory OOS, Deviations. This is a hands-on, non-supervisory position.

Responsibilities

  • Perform routine QA duties such as writing and reviewing GCLP/GMP QA related QMS documentation including but not limited to:

  • QMS controlled documents e.g., Standard Operating Procedures (SOPs), associated forms, worksheets and templates.

  • Initiation and reviews of deviations and root cause investigations

  • Internal and External audits (as necessary)

  • Review and approve manufacturing and QC laboratory investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

  • Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.

  • Initiates and reviews batch records, QC documentation, deviations / non-conformances and associated records in support of clinical batch release.

  • Ensures that all documentation related to investigations is completed, maintained and stored in compliance with the applicable system procedures.

  • Manages and maintains the Document Control system that includes but it is not limited to the organization, issuance, maintenance, archiving and retirement of documents.

  • Ensures that all documentation is controlled and current.

  • Ensures that all employee training is conducted and documented in compliance with all the applicable procedures.

  • Proactively investigates document control issues, identifies improvements and implements good documentation practices at.

  • Ensures that all Laboratory Notebooks and logbooks are controlled, maintained, stored and archived.

  • Orders, issues and maintains all applicable notebooks, logbooks.

  • Ensures that all company records are maintained, stored and archived according to company procedures and the applicable regulatory requirements and standards.

Qualifications

  • Associate Degree required, Bachelor Life Science or Engineering Degree preferred.

  • 2-5+ years of quality/document control experience in the pharmaceutical industry, biotech or medical device industry

  • Working knowledge of compliance best practices for biologics and/or drug products.

  • Some experience with, Cell and/or Gene Therapy or working knowledge of aseptic processing

  • Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211 USP and ICH Guidelines

  • Ability to prioritize, manage time well, multitask, troubleshoot.

  • Comprehensive knowledge of US Quality System Regulatory requirements.

  • Ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience.

  • Demonstrated success in delivery of key milestones against tight timelines.

  • Aptitude to succeed in the culture of a fast-paced, start-up biotechnology company.

  • Strong written and verbal communication skills.

  • Technical writing skills preferred.

  • Strong organizational and computer (Microsoft Word, Excel, Powerpoint, Adobe Acrobat) skills required.

Additional Detail:

  • As your local offices do not support this position, for immediate consideration, please apply online to this posting directly.

  • Resumes in MS Word are preferred.

  • If you have questions about the position, you may contact the recruiter at Leslie.Hesano@kellyservices.com ; however, your resume must be received via the official posting.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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