Materials Operations Compliance Specialist

Samsung Biologics

$81K — $108K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree
  • 3+ years of GMP experience
  • Safety and quality compliance experience preferred
  • Experience driving continuous improvement initiatives preferred
  • Strong verbal and written communication skills
  • Problem-solving skills with demonstrated urgency
  • Knowledge of SAP (ERP) and Microsoft Office Suite

Responsibilities

  • Lead safety and quality investigations in warehouse operations
  • Execute improvement projects for safety and quality compliance
  • Maintain inspection readiness for warehouse operations
  • Ensure timely closure of quality and safety notifications
  • Facilitate warehouse operations risk assessments
  • Author and approve work instructions and SOPs
  • Manage financial controls for the department

Benefits

  • 13 paid holidays
  • Vacation time
  • 401K match
  • Medical, dental and vision benefits effective day one
Full Job Description
Samsung is currently looking for Materials Operations Compliance Specialist to join our team in Rockville, MD. In this role, you'll Lead the execution of warehouse operations safety and quality compliance standards by owning on-time closure of notifications, executing root cause investigations, both owning as well as authoring deviations, writing SOPs in compliance with GMP standards and driving overall improvement plan for the department.

KEY RESPONSIBILITIES:
  • Lead and execute safety and quality investigations including root cause analysis and corrective/preventative (CAPA) actions
  • Lead warehouse improvement plans and executes projects to enhance safety/quality compliance and operational efficiency
  • Establish and maintain warehouse operations inspection readiness state
  • Ensure on-time closure of safety/quality notifications, risks actions, deviations, CAPAs, periodic reviews, change controls
  • Facilitate execution of warehouse operations risk assessments
  • Author, review and approve work instructions, forms, guidelines and SOPs
  • Execute financials controls required for department
  • Perform other duties or projects as assigned by management


Qualifications:
  • Bachelor's degree
  • 3+ years of GMP experience


Preferred:
  • Safety and quality compliance experience
  • Lead and drive continuous improvement initiatives
  • Quality and deviation experience
  • Excellent verbal and written communication skills; with strong presentation skills
  • Strong problem-solving skills
  • Demonstrated sense of urgency
  • Knowledgeable in SAP (ERP)
  • Proficient in Microsoft Office Products (Word, Excel, PowerPoint)


The anticipated salary range for this position in Maryland is $81,000 to $108,000 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.

Benefits:
• 13 paid holidays
• Vacation time
• 401K match
• Medical, dental and vision benefits effective day one of employment

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