Quality Conrol Specialist-Data Analysis
5964 La Place Ct. Carlsbad, CA 92008 US
Job Description
POSITION SUMMARY
Innovative and rapidly growing medical device manufacturer is actively seeking multiple Quality Assurance Specialists-Data Analystis. We are seeking seasoned specialists to leverage their experience to an organization focused on delivering diagnostic instrumentation to patients in real time.
We offer highly competitive compensation and generous benefit packages to all employees!
ESSENTIAL DUTIES & RESPONSIBILITIES
- Provides QA oversight and timely closure of NCRs, Deviations and CAPAs.
- Supports in GMP investigations.
- Provides QA guidance to staff and training on quality system requirements.
- Conducts timely information gathering sessions with cross-functional departments to obtain required information and data to complete an investigation.
- Assess and document product impact within the investigation.
- Conduct thorough root cause analysis and document within the investigation including causal factors identified and any root causes determined.
- Based on root cause outcome, identify and initiate appropriate corrective actions (CAPAs).
- Complete accurate and thorough historical searches within quality system database to identify any similar events and determine if a trend exists or is developing.
- Position requires technical writing capabilities to create clear, concise investigations with appropriate details.
- Own CAPAs and provide project management oversight of the CAPAs to ensure all required corrective actions remain on track and are closed by assigned due dates.
- Participation in process improvements associated with investigation processes may be required.
- Additional responsibilities may include cross-training as a Quality Contact to close investigations from other investigators and to close other reports in multiple quality systems.
- Customer interaction for investigation related issues/questions
- Other duties may be assigned
EDUCATION AND EXPERIENCE
- A Bachelor of Science in related industry is preferred
- 2-3 years of experience required
- Experience working in an FDA regulated
- Environment and in the IVD industry is preferable.
- Experience with Master Control a plus.
- Experience with ERP system a plus.
Skills – Technical
- Proficient in Microsoft Office, especially Word and Excel, for editing and tracking documents.
- Experience with Document and Change Control electronic systems (preferably Master Control)
- Experience working with cross-functional areas (e.g., Manufacturing, Operations)
Skills – General
- Must be a hands-on, self-directed, detail oriented and conscientious individual
- Ability to work independently with minimal supervision.
- Time management skills are essential as investigators will be required to own and manage multiple investigations or CAPAs and adhere to assigned due dates and tight timelines.
- Effective analytical problem solving, judgment and decision-making skills are required
- Ability to work and collaborate with staff from all departments is required.
- Complete work in a timely, accurate and thorough manner.
- Strong time management and organizational skills in a dynamic, constantly changing environment.
- Ability to read, write and analyze complex documents.
- Proven ability to prioritize responsibilities in a high pressure, dynamic, multi-tasking environment.
- Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals.
- Ability to work effectively, exhibit a professional manner and establish constructive working relationships.
- Proven and effective interpersonal communication skills with a demonstrated ability to interact with internal customers in a positive, friendly, and professional manner.
- Excellent presentation skills.
- Adept at influencing, gaining consensus, and capable of overcoming resistance by presenting a powerful case for implementing new initiatives or ideas.
Meet Your Recruiter
Jennifer Lyons
Senior Recruiter & Payroll Specialist
Jenni comes to Marquee Staffing with an extensive background in accounting and business administration. Her primary focus as a talent coordinator is to ensure the inner workings of the office run smoothly and efficiently. Jenni takes pride in providing top-notch assistance to our clientele and is adept at multitasking. For instance, when it comes to the demands of processing payroll and accounts receivable as well as miscellaneous duties pertaining human resources, she handles it all with finesse.
In Jenni’s spare time, she enjoys cheering on her son at his football games. You can also find Jenni headed to a cross fit or a boot camp class, shopping or spending time with family and friends.