Quality Assurance Analyst Jobs Vacancy in Ortho Clinical Diagnostics Pompano Beach
Ortho Clinical Diagnostics Pompano Beach urgently required following position for Quality Assurance Analyst. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.
Quality Assurance Analyst Jobs Vacancy in Ortho Clinical Diagnostics Pompano Beach Jobs Details:
The Career Potential
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It’s who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
We are seeking a Quality Assurance Analyst II to review batch records and release biological products according to established procedures or approved protocols.
- Independently review batch records at various stages of the manufacturing process (from product formulation, QC testing through final product) and approves their final release once it has been determined that all compliance and procedural requirements have been met.
- Verify batch record data is accurate; identify batch record issues and open non-conformance's where required
- Performs batch record review for customer complaints including final product and formulations. Analyzes each customer complaint to ensure that there are no contributing factors found during batch record review related to the Customer complaint.
- Issues manufacturing batch record according to the production schedule.
- Trains other reviewers in good documentation practices and the compliance of current quality standard.
- Writes and/or assists others in writing standard operating procedures.
- Generates moderately complex statistical summaries
- Comfortable speaking with internal and external auditors
- Adheres to documentation standards required by Good Manufacturing Practices (GMP).
- Performs other duties as assigned.
- A minimum of a Bachelor’s degree in Science with a minimum of 2 years of experience at a medical or manufacturing facility; or equivalent combination of education and experience. An educational focus in Medical Technology and experience in Blood Banking will be preferred.
- Must be able to rapidly acquire and maintain in-depth product knowledge.
- Strong attention to detail.
- Ability to meet deadlines and prioritize
- Excellent written/verbal communication and computer skills are essential.
- Candidate should be familiar with regulations and guidelines of all applicable regulatory agencies, such as FDA (QSR/cGMP), OSHA, ISO (including ISO14001), and OCD Health, Safety and Industrial Hygiene.
For this position we will not sponsor applicants for work visas.
Ortho Clinical Diagnostics believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. Ortho Clinical Diagnostics is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at firstname.lastname@example.org
Pay Transfer Notice