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Quality Assurance Specialist

2 months ago

Cambridge, Massachusetts, United States Alphanumeric Systems Inc. Full time

Alphanumeric Systems Inc. is seeking a highly skilled and experienced Quality Assurance Specialist to join our dynamic team in Cambridge, MA. We partner with a leading client dedicated to improving lives through medical and pharmaceutical advancements.

In this role, you will play a crucial part in ensuring that our products meet both local and global quality standards. You will oversee the quality assurance process, promoting a culture of excellence throughout all operations.

Responsibilities:
  • Execute all activities adhering to established quality and regulatory standards and procedures.
  • Champion a quality-focused mindset and drive continuous improvement initiatives within the organization.
  • Provide proactive communication with customers, ensuring timely escalation and resolution of issues. Maintain clear and concise communication across all departments.
  • Support batch release processes for drug substances, including documentation compilation as needed.
  • Conduct thorough reviews of manufacturing batch records to ensure compliance with cGMPs and regulatory requirements.
  • Provide on-the-floor support to the Manufacturing team, ensuring smooth operations.
  • Demonstrate proficiency in SAP transactions related to batch record review.
  • Possess a strong understanding of quality systems such as Change Control, CAPAs, Deviations, Self-inspection auditing, QA reporting, and approval of GMP documentation.
  • Contribute to maintaining GMP compliance and inspection readiness within the organization. Assist in coordinating work for the QA Operations team to facilitate timely product release.
Requirements:
  • High School Diploma or equivalent with 8+ years of experience in a cGMP environment, OR Associate Degree with 6+ years of experience, OR Bachelor's Degree with 4+ years of experience.
  • Previous experience working with quality systems and overseeing cGMP production operations, including batch release, SAP, and batch record review.
Preferred Qualifications:
  • Bachelor of Science or Bachelor of Arts degree in a scientific discipline.
  • Demonstrated experience in regulatory inspection activities.
  • Ability to effectively manage multiple projects simultaneously within tight deadlines.
  • Strong analytical and problem-solving skills, with the ability to prioritize tasks and adapt to changing priorities.
  • Working knowledge of cGMPs and associated regulatory requirements for pharmaceutical/biopharmaceutical product manufacturing, testing, and release.
  • Experience working successfully both independently and as part of a team.
  • Excellent verbal and written communication skills.