DescriptionPosition Summary
Responsible for ensuring that the quality of products being manufactured meet the prescribed quality levels. Performs Quality Assurance activities, including review of manufacturing and final product release activities. Performs Quality oversight/observations for in-process verification/inspection activities within manufacturing areas, such as reworks.
Essential Duties And Responsibilities
Qualifications
Responsible for ensuring that the quality of products being manufactured meet the prescribed quality levels. Performs Quality Assurance activities, including review of manufacturing and final product release activities. Performs Quality oversight/observations for in-process verification/inspection activities within manufacturing areas, such as reworks.
Essential Duties And Responsibilities
- Monitors/reviews the quality system including records and results from processes and procedures to ensure product Quality and compliance for any/all products (i.e. cassettes/consoles).
- Ensures documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements.
- Reviews Quality Controls records and certificates to ensure accuracy and acceptability of analytical results
- Maintains knowledge of current regulatory requirements pertaining to drug/device manufacturing.
- Performs label control functions
- Participates in investigations of quality issues as required.
- Supports Quality functions for batch record and label issuance, personnel and material flow, and batch release.
- Performs QA release of final products in accordance with procedures
- Reviews Standard Operating Procedures (SOPs) for manufacturing processes (may assist with revisions as needed).
- Participates in continuous improvement objectives to assure compliance with regulations.
- Develops and/or maintains metrics and trending reports for compliance related activities.
- Supports internal audits and regulatory inspections.
- Leads and mentors Quality personnel, including promoting quality culture and supporting quality objectives.
- Performs QA receiving, issuance inventory
- Performs Quality observations and in-process inspection/verification activities, such as reworks, on the production floor to provide Quality oversight (as assigned by Management)
- Reviews applicable logbooks
- Other related duties as assigned
Qualifications
- At least 2 years, minimum, as a Quality Assurance Associate (or equivalent experience)
- College degree required, preferably in a scientific discipline.
- 2+ years’ experience in FDA/cGMP regulated environment. FDA 21CFR210/211/820 and ISO14845.
- Strong communication skills with keen attention to detail.
- Must have strong organization skills with attention to detail and accuracy.
- Proficiency in the use of MS Word, Excel and Outlook. MS Access and other software tools, a plus.
- Must have good basic mathematical skills
- Excellent verbal and written communication skills in English
- Teamwork-Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building apositive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed
- Organizational Support-Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values
- Planning/Organizing-Prioritizes and plans work activities; Uses time efficiently; Sets goals and objectives;
- Quality-Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Ability to lift up to 50 pounds
- Occasionally required to Bend, Stoop, or reach
- Ability to sit for two hours at a time
- Ability to reach above head below waist
- Correctable vision to 20/20
- Mobility to move throughout building
About the company
Company website•Pharmaceutical Manufacturing
Vero biotech is an emerging biotechnology company focused on the design, development, and commercialization of next generation inhaled nitric oxide (NO) delivery systems to address unmet medical needs of patients with cardiopulmonary conditions.
At Vero Biotech, our mission is to improve the lives of patients by leading the development of innovative technologies for inhaled NO delivery in the acute care hospital setting and beyond, wherever Nitric Oxide treatment is needed. We strive to exceed customer expectations in terms of safety, efficacy, and growth by focusing on the science, development, and commercialization of our innovations.