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Associate - QA Batch DispositionBioSpace, Inc. • Concord, California, United States
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Associate - QA Batch Disposition

BioSpace, Inc.
  • US
    Concord, California, United States
  • US
    Concord, California, United States
Jetzt Bewerben

Über

Job Responsibilities The Quality Assurance Batch Disposition Team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The QA Batch Disposition is responsible for the final disposition of Semi‑Finished and/or Finished drug combination products. The QA position is essential for ensuring GMP compliance in the qualification, validation, control strategy and startup of operations to ensure regulatory approval of the facility. Electronic batch records with high integration and focus on data integrity will be utilized to confirm manufacturing production.
Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e‑release process and startup of new systems
Perform final batch disposition of semi‑finished and/or finished drug product and combination product batches, to ensure high quality medicine (GMP Compliance) is released to market in a timely manner
Effectively own/review/approve GMP documents to ensure quality attributes are met (i.e.: Deviations, procedures, protocols, specifications, and change controls)
Additional job duties as required
Basic Requirements
Bachelor’s degree in STEM
Experience working in the pharmaceutical or medical device industry in QA roles
Previous batch disposition experience
Ability to make technical decisions, provide guidance to the site
Proficiency with applicable computer systems
Demonstrated strong oral and written communication skills
Demonstrated interpersonal skills and the ability to work as a team
Root cause analysis/troubleshooting skills
Demonstrated attention to detail and ability to maintain quality systems
Previous regulatory inspection readiness and inspection execution experience
Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H‑1B or TN status) for employment positions on the B or S paths or at levels M1‑M2 or R1‑R4.
Additional Skills/Preferences
Ability to work 8‑hour days – Wednesday through Sunday Day Shift (not eligible for remote work)
Ability to work overtime and be on‑call as required
Proven ability to work independently or as part of a Team to resolve an issue
Previous experience with Event and Change Management process
Proficiency with SAP, MES, and Trackwise
Previous experience with device and parenteral product materials
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400.
Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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  • Concord, California, United States

Sprachkenntnisse

  • English
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