Clinical Sr. QA Specialist - CLIA/CAP

Primary Responsibilities for Role

• Independently handles complaints, investigations, performs root causes, assigning additional actions as necessary.
• Review/update/create SOPs to standardize current and new processes.
• Applies knowledge of regulatory bodies such as, CAP, CLIA, AABB, CFR, to identify, manage, and follow-up on Quality events.
• Leads cross-functional teams from internal departments/outside vendors to establish appropriate processes for product quality improvements. Ensures implementation/sustainability and monitors the field quality of the improvements.
• Represents QA interests on special projects related to area of expertise.
• Plan and conduct scheduled internal audits to assess compliance with FDA, ISO, MDR, and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Pro-actively investigate, identify, and implement best in class Quality Systems practices and implement/manage improvement projects within the organization; (CAPA, QMP, StAR, Lean, 5S).
• Drive awareness and compliance with applicable standard operating procedures/ work instructions / standards and regulations to meet, comply and champion all quality and regulatory commitments.
• Interacts with regulatory and partner auditors/inspectors.
• Will also estimate, plan, schedule and review own and others’ work products and be accountable for the quality work delivered.

Knowledge, Skills, and Abilities

• Advanced knowledge of complaint handling, testing instrument (hardware and software), QC, Manufacturing & Inventory processes.
• Working knowledge of QMS, Microsoft Word, Excel (or other data trending/analysis tools), Power Point and related functions including the formulation of graphs.
• Organizational skills, attention to detail and ability to prioritize in a fast-paced environment is essential.
• Must demonstrate initiative, independence, balanced assertiveness, flexibility, and team orientation.
• Ability to train and mentor within and outside the group.
• Can plan and coordinate own work according to higher-level project schedules. Including direction of contract personnel to ensure projects come to fruition in a timely manner.

Education

• Requires BA or BS in biology, chemistry, biochemistry or any science related field.
• Quality certifications such as MT, MLS,CLS and ASQ or equivalent are a plus.
• Experience: 5-8 years related quality experience in complaint handling and investigation or a Master’s degree with 3-6 years of experience.

Benefits

• Salary in line with the market as well as an annual bonus target
• Paid Vacation, PTO, holidays
• Parental leave program
• Professional development opportunities (training, career development)
• Gym pass, Employees perks program
• 401 (K) Retirement Plan (Grifols will match 100% on the first 4% of eligible compensation you contribute, and 50% on the next 2% of eligible compensation you contribute)
• Health insurance: Medical, Dental, Vision
• Travel accident insurance; Life and AD and D Insurance, Short- & Long-Term Disability Insurance
• Health Savings Account, Flexible Spending Account
• Critical Illness, Accident, Hospital Indemnity coverages
• Adoption benefits