Quality Assurance Specialist, I

Role Summary

The Quality Assurance Specialist, I conducts day-to-day QA activities in a regulated manufacturing environment, including batch record review, media disposition, label issuance, archiving, and final product packaging and release. The role requires gowning into ISO 7 cleanroom areas to inspect final product. Schedule is in-office Tuesday - Saturday.

Responsibilities

• Perform, as well as ensure that the review of batch records and release of intermediates is performed within required timeframes outlined in SOPs.
• Responsible for the packaging and final batch disposition.
• Responsible for inspection of final product within an ISO 7 cleanroom
• Support day to day operations, including batch record review, label issuance, archiving and verification with supervision oversight and in a timely manner.
• Follow oral and written procedures for review and release of intermediate and final product.
• Support projects as a QA resource.
• Identifies deficiencies and works with cross functional departments to remedy them.
• Identifies issues and provides recommendations for process improvements within the department.
• Revise Standard Operating Procedures.
• Other duties as assigned.

Qualifications

• Required: High School degree/GED with 2 years of relevant pharmaceutical/biotech experience or Bachelors plus 0-1 years of relevant pharmaceutical/biotech experience
• Required: Basic working knowledge of GMP regulations
• Preferred: Strong written and verbal communication skills.
• Preferred: Strong organization and time management skills.
• Preferred: Proficient in MS Word and Excel
• Preferred: Experience with electronic batch records, ERP systems and Quality Management Systems (Examples: TrackWise and Veeva).

Additional Requirements

• Ability to lift and transport up to 30 lbs.
• Must be able to work one weekend day.
• Must be able to support rotating holiday coverage.
• Must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product.
• Must be able to gown into CNC areas