- Design, implement and manage the installation and use of Master Control to handle the electronic documentation of Market Complaint, Deviation, OOS, Outliers, Root Cause Investigation, CAPAs, Recall, Change Controls, SOP and training.
- Chair the Investigations review Board (IRB) meetings, issue minutes and follow up on corrective and preventative actions.
- Manage and trend the deviation process while ensuring that a thorough investigation report is completed in a timely manner using proven root cause analysis tools.
- Manage the review, tracking, GMP compliance and approval of Change Controls for Production Processes, Facilities and Equipment.
- Manage all CAPA commitments to ensure timely completion of the outlined tasks and effectiveness.
- Manage the Customer Complaint system for both product and adverse event complaints; ensuring investigations are performed on time and any notifications meet regulatory reporting requirements (i.e. Field Alert Reports (FARs), 3 day and 15 day alerts, etc.).
- Manage the collation and generation of Annual Product Reviews (APRs); ensuring the timely approval of all APR's and the continued improvement of the generation process and the effectiveness of the utilization of report contents and data.
- Set and support company goals for the Quality Systems group as well as monitor the results and employee performance.
- Oversee the interviewing, hiring, training and development of all quality systems personnel, ensuring employees can function effectively in a team-base culture.
- Develop and maintain site quality metrics in accordance with new FDA guidance.
- Act as the SME for Deviations, CAPAs, Change Controls, Complaints and Site Quality Metrics during regulatory or FDA cGMP inspections.
- Maintain KPIs related to laboratory accuracy and conformance with SOPs, regulations and Guidelines and present to the Quality Council.
- Develop and maintain monthly Site Quality Council meeting, as well as coordinate and handle weekly Investigation Review Board meetings.
- Review of Annual product quality reviews.
- Preparation, approval of Standard Operating Procedures.
- Preparation and review Quality Risk Management for process, area and equipment.
- Assist with quality improvement initiatives as needed.
- Assist with development/writing of SOPs or other quality documents and/or reports as needed.
- Provides consultation on quality and compliance tropics in the area of expertise.
- May serve as client quality liaison and/or quality host of client audits; coordinates responses to client audits.
- Effectively performs a variety of duties, on schedule, with accuracy and competency.
- Performs other duties as assigned.
- Complies with company polices and SOPs.
- 10 years of experience in the pharmaceutical industry preferred.
- Good written and oral communication skills.
- Experience in statistical analysis, process capability reviews with software preferred.
- Ability to act independently.
- Excellent interpersonal, verbal and written communication skills.
-
Assurance Manager
2 weeks ago
Marcum Search Hartford, United StatesMarcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading techn ...
-
Assurance Manager
2 weeks ago
CohnReznick Hartford, United StatesAs CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they doWe currently have an exciting ...
-
Assurance Manager
2 weeks ago
Marcum LLP Hartford, United StatesMarcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading techno ...
-
Assurance Manager
2 weeks ago
CohnReznick Hartford, United StatesAs CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they do · We currently have an exciti ...
-
Assurance Manager
1 week ago
Whittlesey Hartford, United StatesJob Description · Job DescriptionWhen you work at Whittlesey, you join a diverse team who provide today's business leaders with leading assurance, advisory, tax, and technology services. Whittlesey is proud to announce that we have been named a Best of the Best Firm by INSIDE Pub ...
-
Assurance Senior Manager
2 weeks ago
CohnReznick Hartford, United StatesAs CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they doWe currently have an exciting ...
-
Assurance Senior Manager
2 weeks ago
Marcum LLP Hartford, United StatesMarcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading techno ...
-
Assurance Senior Manager
2 weeks ago
CohnReznick Hartford, United StatesAs CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they do · We currently have an exciti ...
-
Assurance Manager
2 weeks ago
Creative Financial Staffing Hartford, United States? Assurance Manager ? · Ready for the next step in your public accounting career? · Why we like this opportunity: Assurance Manager · Growth: Rapidly expanding firm with ample opportunities for advancement. · Flexibility: Hybrid work model - onsite 3 days a week. · Collabora ...
-
Assurance Manager
4 weeks ago
Creative Financial Staffing Hartford, United States Assurance Manager · Ready for the next step in your public accounting career? · Why we like this opportunity: Assurance Manager · Growth: Rapidly expanding firm with ample opportunities for advancement. · Flexibility: Hybrid work model - onsite 3 days a week. · Collabora ...
-
Assurance Manager
6 days ago
Marcum LLP Hartford, United StatesMarcum LLP offers a great career with exceptional benefits. · There's a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading techno ...
-
Assurance Manager
2 weeks ago
Marcum LLP Hartford, United StatesAssurance Manager - Hartford page is loaded · Assurance Manager - Hartford · Apply · locations · Hartford, CT · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · R3929 · Marcum LLP offers a great career with exceptional benefits. · There's a ...
-
Assurance Manager
6 days ago
Creative Financial Staffing Hartford, United StatesAssurance Manager · Ready for the next step in your public accounting career? · Why we like this opportunity : · Assurance Manager · Growth: · Rapidly expanding firm with ample opportunities for advancement. · Flexibility: · Hybrid work model - onsite 3 days a week. · Col ...
-
Assurance Manager
1 week ago
CohnReznick Hartford, United StatesOpportunity ID · 6242 · Department(s) · Assurance · Location(s) · Hartford · Function · Audit · Job description · As CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Assur ...
-
Assurance Manager
2 weeks ago
CohnReznick Hartford, United StatesAs CohnReznick grows, so do our career opportunities. As one of the nation's top Professional Services and Business Advisory firms, we foster teams in Advisory, Assurance, and Tax services that value innovation and collaboration in everything they do · We currently have an exciti ...
-
Senior Assurance Manager/Director
1 week ago
Whittlesey Hartford, United StatesJob Description · Job DescriptionWhen you work at Whittlesey, you join a diverse team who provide today's business leaders with leading assurance, advisory, tax, and technology services. · Whittlesey is proud to announce that we have been named a Best of the Best Firm by INSIDE ...
-
Senior Assurance Manager/Director
2 weeks ago
Whittlesey Hartford, United StatesJob Description · Job DescriptionWhen you work at Whittlesey, you join a diverse team who provide today's business leaders with leading assurance, advisory, tax, and technology services. · Whittlesey is proud to announce that we have been named a Best of the Best Firm by INSIDE ...
-
Quality Assurance Manager
2 weeks ago
Cherokee Nation Businesses Front Royal, United StatesJob DescriptionFacilities Quality Assurance ManagerThis position requires an active Top Secret or Public Trust clearance or the ability to obtain a Top Secret or Public Trust clearance to be considered.Assists with facility management and project quality assurance in support of t ...
-
Quality Assurance Manager
3 weeks ago
Cherokee Nation Businesses Front Royal, United StatesJob DescriptionFacilities Quality Assurance ManagerThis position requires an active Top Secret or Public Trust clearance or the ability to obtain a Top Secret or Public Trust clearance to be considered.Assists with facility management and project quality assurance in support of t ...
-
Quality Assurance Manager CT
3 days ago
Gallagher Hartford, United StatesAbout Us: Join our growing team of dedicated professionals at Gallagher Bassett, who guide those in need to the best possible outcomes for their health and wellbeing. You'll be part of a resilient team that works together to redefine the boundaries of excellence. At our organizat ...
Quality Assurance Manager - Newtown, United States - KVK Tech
Description
Job Description
Job DescriptionDepartment
Quality Assurance
Job Title
Manager
FLSA Status
Exempt
Reports To
Head Quality Operations Management
1. Role Purpose:
The Quality Assurance Manager ensures quality and compliance of the facility with applicable regulatory requirements. These activities may include reviewing documents and data, conducting process-focused audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analyses and reporting metrics where required, as well as performing quality and compliance training, as needed. May serve as quality host for client audits and inspections and provide support during regulatory inspections as well as conducting and/or coordinating auditing for vendor quality. Assists with the development of SOPs, specifications, policies or other quality documents as needed.
2. Key Duties & Responsibilities:
3. Typical Supervisory Responsibility:
Serves as an effective member of the Quality team and may serve as a mentor to other Quality employees in the area of expertise.
4. Education & Experience:
Education Requirement
BS Chemistry or related science field, MS preferred.
5. Technical competencies/ Certifications/ Licenses:
Technical competencies
6. Physical demand and Work environment:
a. Physical demands:
While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception
Quality Assurance Manager professionals in Hartford
-
Michael Sauvron
Competitive Operations - Esports
-
RICHARD BROWN III
Human Resources Executive
-
Mahesh S
Vice President Automation, Analytics & DigitalTech