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Sr. Quality Specialist, Material Management

Karwell Technologies

Boston, MA

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JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Change Control, Change Management, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Detail Oriented, Documentation, ERP (Enterprise Resource Planning), File Maintenance, GMP (Good Manufacturing Practices), Inventory Cycle Counts, Inventory Management, Manufacturing, Materials Management, Materials Tracking, Metrics, Multitasking, Onboarding, Presentation/Verbal Skills, Quality Assurance, Quality Management, Release Management/Engineering, Standard Operating Procedures (SOP), Supply Chain, Team Lead/Manager, Team Player, Vendor/Supplier Evaluation, Writing Skills
LOCATION
Boston, MA
POSTED
30+ days ago
Responsibilities:
  • Provides QA support overseeing the management of incoming raw materials and consumables for internal manufactured products.
  • Reviews GMP documentation for incoming raw materials and consumables for internal manufactured products.
  • Performs final review of executed GMP documentation for the management of materials and determines acceptability by using standard operating procedures.
  • Ensures presence and acceptability of all required documentation prior to the release of raw materials and consumables.
  • Supports the day-to-day management of incoming raw materials and consumables release process.
  • Provides QA support in the management of SCARs assisting in determining impact to incoming raw materials and consumables as well as supporting vendor investigations.
  • Maintains and archive files such that documents are readily available and easily retrievable.
  • Assists department with weekly/monthly/quarterly Quality System data review metrics and reporting pertaining to materials management.
  • Communicates proactively with internal and external partners as well as with management.
  • Escalates critical and major findings to Quality management.
Requirements:
  • Bachelor's degree in a scientific or allied health field.
  • 5 years of relevant industry experience such as materials management, supply chain, quality assurance and/or manufacturing in biotechnology/regulated pharmaceutical environment.
  • Knowledge of cGMP's in a pharmaceutical setting.
  • Ability to collaborate effectively within a team.
  • Ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects.
  • Strong attention to detail.
  • Effective communication skills, both verbal and written.
  • Demonstrated success by independently leading cross-functional teams.
Must Have Experience with the following:
  • Oversee Raw Material Inventory Management, Segregation, Storage, and Cycle Count.
  • Responsible for review and approve raw material receiving packets. Manage the raw material status in ERP system.
  • Approve new material onboarding, qualification protocols, and material qualification reports for VCGT programs.
  • Responsible for Vendor Change Notification, Supply Corrective Action Request, Raw Material related deviations, and change controls.
  • Provides QA support in the management of SCARs, Change Controls, Vendor Change Notifications, Deviation Investigations.
  • Past experience working in established biopharma companies with commercial QA Operation experience.

About the Company

K

Karwell Technologies

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