Senior QA Specialist

Location
Burlingame, California, United States
Posted
Jul 20, 2021
Ref
4584251003
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SUMMARY OF ROLE

Inflammatix is seeking a Senior QA Specialist to support the Quality Management System. The Quality Assurance Specialist will be responsible for supporting Document Control, training administrative processes and supporting internal & external audits, exception and change management, and other QMS initiatives

PRIMARY RESPONSIBILITIES
  • Assist with Quality Management Systems processes as needed
  • Support Document Control Program: establishment, approval, and maintenance of company Quality Operating Procedures, Standard Operating Procedures, work instructions, etc.
  • DCO Approval process: assist with managing the approval processes for quality documents; collaborate with document reviewers to consolidate comments and resolve discrepancies
  • Support and/or administer training program
  • Support Change Management Program: manage identification and tracking of changes to approved procedures, validated software, and qualify equipment/facilities
  • Support exception management processes: review CAPAs for compliance; identify and track key deliverables associated with process events or changes to aid in implementing corrective actions
  • Internal Audit program: Assist with conducting internal audits of QMS processes to verify compliance with FDA QS, ISO 13485:2016 and other applicable requirements
  • Support external audit management processes
  • Work cooperatively in a team environment to maintain cross-functional and cross-site processes and procedural consistency for quality system records
  • Assist in supplier qualification and reassessment activities
  • Analyze non-compliance issues to identify trends and propose resolutions
  • Track and facilitate investigations in cross functional team discussions in support of closing non-conformances, change controls, and CAPAs
  • Participate in projects that support continuous improvement efforts
  • Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies

MINIMUM QUALIFICATIONS
  • Bachelor's degree in a physical or biological science
  • Practical, hands-on experience in Quality Management Systems; minimum of 3 years of experience
  • Excellent problem-solving skills; demonstrated strength intact and diplomacy with internal and external collaborators
  • Ability to work independently and exercise good judgment
  • Excellent written and communication skills
  • Excellent interpersonal skills and ability to work on teams and with others in a positive and collaborative manner
  • Excellent prioritization and organizational skills

PREFERRED QUALIFICATIONS:
  • Experience working in an FDA-regulated environment; familiarity with ISO 13485 preferred
  • Experience with document control, training, change control, deviations, nonconformances, CAPA, internal and external audits, complaint handling, and/or new product development preferred
  • IVD experience preferred

COMPENSATION AND CLASSIFICATION:
  • Classification: Full-time
  • Compensation: Competitive and commensurate with experience; includes equity package
  • Benefits: Medical, dental, and vision; 401(k) and more


Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic partner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable law