Clinical Sr. QA Specialist - CLIA/CAP
GRIFOLS, S.A.•San Marcos, CA
•Remote
About The Position
The QA Sr. Specialist plays a pivotal role in laboratory operations, providing essential oversight and guidance, with a primary focus on clinical and manufacturing testing. Their multifaceted responsibilities encompass complaint handling, customer support, leading improvement initiatives, and meticulous document review. In addition, they serve as the key interface between quality assurance and auditing bodies, facilitating effective communication with both external auditors and internal departments. They may also supervise relevant tasks without formal evaluations.
Requirements
- 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.
- Requires BA or BS in biology, chemistry, biochemistry or any science related field.
- 5-8 years related quality experience in complaint handling and investigation or a Master’s degree with 3-6 years of experience.
Nice To Haves
- Quality certifications such as MT, MLS,CLS and ASQ or equivalent are a plus.
Responsibilities
- 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 ofInteracts 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
