Senior Specialist I, QA

AGC Biologics • $72K — $116K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Pharmaceutical Sciences, Chemistry, or a related field.
  • 1-2 years of experience in a QA role, ideally within a GxP-regulated context.
  • Strong knowledge of regulatory requirements and industry standards.
  • Excellent analytical, problem-solving, and communication skills.
  • Ability to work independently and manage priorities effectively.

Responsibilities

  • Conduct release processes and verify necessary documentation.
  • Execute sell bank release activities in line with regulations.
  • Develop and facilitate training programs for QA and other departments.
  • Ensure original documentation support is accurate and complete.
  • Provide support to various departments based on business needs.
  • Collaborate with cross-functional teams to enhance processes.
  • Assist with audits and other related activities.

Benefits

  • Comprehensive training and development opportunities.
  • Opportunity to collaborate with cross-functional teams.
  • Support for continuous learning and professional growth.
  • Engagement in compliance and regulatory improvement initiatives.
Full Job Description
Job Title: QA Specialist I
Reports to: Quality Assurance Manager
Location: US-CRAN

Job Summary:
We're seeking an experienced QA Specialist to join our Quality Assurance team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and company standards, focusing on release processes, documentation.

Key Responsibilities:

Perform release processes, including review and verification of documentation
Conduct sell bank release activities, ensuring compliance with regulatory requirements
Develop and deliver training programs for QA staff and other departments as needed
Provide original documentation support and ensure accuracy and completeness
Offer additional support to various departments as per business requirements
Collaborate with cross-functional teams to identify and implement process improvements

Support audits and other activities as required.

Qualifications:

Bachelor's degree in a relevant field (Pharmaceutical Sciences, Chemistry, etc.)
Proven 1-2 year experience in a QA role, preferably in a GxP-regulated environment
Strong knowledge of regulatory requirements and industry standards
Excellent analytical, problem-solving, and communication skills
Ability to work independently and prioritize tasks effectively

Salary range for this role is 72k-116k

Job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

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