Senior Quality Assurance Specialist

Taking care of people is at the heart of everything we do, and we start by taking care of you!!! A career at Grifols means experiencing our culture of caring. It’s an opportunity to do something meaningful, each day. It means sharpening your skills and growing your career. And it means working in an environment that celebrates diversity and is fair and inclusive!

Summary

: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

.

Primary Responsibilities for Rol

• e:Independently handles complaints, investigations, performs root causes, assigning additional actions as necessar
• y.Review/update/create SOPs to standardize current and new processe
• s.Applies knowledge of regulatory bodies such as, CAP, CLIA, AABB, CFR, to identify, manage, and follow-up on Quality event
• s.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 improvement
• s.Represents QA interests on special projects related to area of expertis
• e.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 action
• s.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/inspector
• s.Will also estimate, plan, schedule and review own and others’ work products and be accountable for the quality work delivere

d.

Knowledge, Skills, and Abiliti

• es:Advanced knowledge of complaint handling, testing instrument (hardware and software), QC, Manufacturing & Inventory process
• es.Working knowledge of QMS, Microsoft Word, Excel (or other data trending/analysis tools), Power Point and related functions including the formulation of grap
• hs.Organizational skills, attention to detail and ability to prioritize in a fast-paced environment is essenti
• al.Must demonstrate initiative, independence, balanced assertiveness, flexibility, and team orientati
• on.Ability to train and mentor within and outside the gro
• up.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 mann

er.

Educat

ion:Requires BA or BS in biology, chemistry, biochemistry or any science related fi

eld.Quality certifications such as MT, MLS,CLS and ASQ or equivalent are a p

lus.

Experi

ence:5-8 years related quality experience in complaint handling and investigation or a Master’s degree with 3-6 years of experi

ence.

Equival

ency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of exper

ience.

More about us, benefits we provi

• de you:Salary in line with the market as well as an annual bonus
• targetPaid Vacation, PTO, h
• olidaysParental leave
• programProfessional development opportunities (training, career devel
• opment)Gym pass, Employees perks
• program401 (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 cont
• ribute)Health insurance: Medical, Dental,
• VisionTravel accident insurance; Life and AD and D Insurance, Short- & Long-Term Disability In
• suranceHealth Savings Account, Flexible Spending
• AccountCritical Illness, Accident, Hospital Indemnity co
• veragesAdoption b

enefits