- Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
- Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
- Work directly on technical investigations relating to Product Quality Complaints
- Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
- Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
- B.S. in chemistry or related scientific field
- Minimum 6-8 years related experience in a pharmaceutical manufacturing environment.
- Working knowledge of cGMPs, GLPs
- Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data
- Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with parenteral drug manufacture.
- Base salary range of $110,000 to $118,000 based on experience and qualifications, as well as geographical market and business considerations.
- +10% bonus
- Paid time off and holidays
- 401K and company match
- Health insurance
- Relocation Assistance
-
Functional Quality Assurance Manager
1 week ago
Lockheed Martin Chelmsford, United States**Job ID**: 661173BR · **Date posted**: Feb. 15, 2024 · **Program**: Functional · **Description**:Lockheed Martin is seeking to hire a Functional Quality Assurance Manager for the Chelmsford, MA facility. Responsible for overseeing processes and leading direct-report team members ...
-
Quality Assurance Manager
3 weeks ago
DV Die Cutting Inc. Danvers, United States**Overview**: · **Duties**: · - Develop and implement quality assurance policies and procedures · - Maintain ISO documentation · - Conduct regular quality audits to identify areas for improvement · - Oversee quality control processes, including QA/QC inspections · - Collaborate w ...
-
Quality Assurance Manager
3 weeks ago
EPM Scientific Billerica, United StatesTitle: Quality Assurance Manager (Medical Device) · Location: Billerica, MA · A pharma/med device company is seeking a Quality Manager to spearhead Quality activities related to their combination products. The Quality Manager will be responsible for all aspects of QA for medica ...
-
Quality Assurance Manager
2 weeks ago
EPM Scientific Billerica, United StatesTitle: Quality Assurance Manager (Medical Device) · Location: Billerica, MA · A pharma/med device company is seeking a Quality Manager to spearhead Quality activities related to their combination products. The Quality Manager will be responsible for all aspects of QA for medical ...
-
Quality Assurance Manager
2 weeks ago
EPM Scientific Billerica, United StatesTitle: Quality Assurance Manager (Medical Device) · Location: Billerica, MA · All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description. · A pharma/med device company is seeking a Quality Manager to spe ...
-
Quality Assurance Manager
3 weeks ago
Wimmer Solutions Billerica, United StatesSENIOR ASSOCIATE, COMPLIANCE (PRODUCT QUALITY) · BILLERICA, MA (ONSITE) · At Wimmer Solutions, we believe care creates community. We work smart; we have built a reputation for results-oriented, innovative, business and technology solutions that help companies execute on their s ...
-
Quality Assurance Manager
1 week ago
Wimmer Solutions Billerica, United StatesSENIOR ASSOCIATE, COMPLIANCE (PRODUCT QUALITY) · BILLERICA, MA (ONSITE) · At Wimmer Solutions, we believe care creates community. We work smart; we have built a reputation for results-oriented, innovative, business and technology solutions that help companies execute on their st ...
-
Quality Assurance Manager
2 weeks ago
Wimmer Solutions Billerica, United StatesSENIOR ASSOCIATE, COMPLIANCE (PRODUCT QUALITY) · BILLERICA, MA (ONSITE) · If your skills, experience, and qualifications match those in this job overview, do not delay your application. · At Wimmer Solutions, we believe care creates community. We work smart; we have built a re ...
-
Compliance Assurance Manager
1 day ago
Citizens Westwood, United States**Description** · The Compliance Assurance function is a part of the second line of defense and is responsible for providing independent assurance regarding the adequacy, effectiveness, and sustainability of regulatory risk management and control processes to ensure regulatory, c ...
-
Quality Assurance Manager
12 hours ago
RADcube Boston, United States**Quality Assurance Manager**: · **Type**:Contract | **Location**:Boston, Massachusetts · Primary Responsibilities · - Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · - Track, measure, and report on progress ...
-
Quality Assurance Test Manager
3 weeks ago
NavitsPartners Cambridge, United States**Position**: Quality Assurance Test Manager · **Duration**: 18-24 months · **Hours Per Week**: 37.5 · **Location**: Hybrid (Boston, MA) · **Position Summary**: · **Quality Assurance and Test Management**: · - Plan, execute, and lead testing efforts to ensure compliance with PROG ...
-
Manager, Quality Assurance Operations
3 weeks ago
ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Quality Assurance Program Manager
1 week ago
INTEGRA TESTING SERVICES Needham, United StatesThe Quality Manager is responsible for leading the Quality Program for all CE Services locations and managing the onsite Microbiology Laboratory. · The Quality Manager assumes overall responsibility in ensuring that the division maintains operational and quality systems in a stat ...
-
Quality Assurance Compliance Manager
3 weeks ago
Oxenham Group Billerica, United StatesThis range is provided by Oxenham Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Base pay range · $160,000.00/yr - $175,000.00/yr · Direct message the job poster from Oxenham Group · Medical Device Quality & Regulat ...
-
Senior Manager, Quality Assurance
3 weeks ago
Sun Pharma Billerica, United StatesJob Summary · for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Ensure all medical devices manufactured meet established specifications. · compliance of establish Quality Management System (QMS ...
-
Senior Manager, Quality Assurance
4 days ago
Sun Pharma Billerica, United StatesJob Summary · Responsible for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Ensure all medical devices manufactured meet established specifications. · Ensure compliance of establish Quality Mana ...
-
Senior Manager, Quality Assurance
2 weeks ago
Sun Pharma Billerica, United StatesJob Summary · for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Ensure all medical devices manufactured meet established specifications. · compliance of establish Quality Management System (QMS ...
-
Manager, Supplier Quality Assurance
1 week ago
Lantheus Medical Imaging Inc Billerica, United StatesJob Description · Job DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care wi ...
-
Emerald Enterprises Cambridge, MA, United States FreelanceAre you looking to take the next step in your career? At Brunel, you have the opportunity to continuously develop yourself with renowned clients across industries. Take the decisive step in your career today and apply with us as a Project Manager for Automotive Quality and Produc ...
-
Vertex Pharmaceuticals Boston, United StatesJob Description · General Position Summary: · The Audit and Inspection Management Manager is responsible for the execution of audit and inspection management assigned activities, inclusive of internal and external processes, contributing to and executing audit plans, supporting i ...
Quality Assurance Manager - Billerica, United States - Wimmer Solutions
Description
SENIOR ASSOCIATE, COMPLIANCE (PRODUCT QUALITY)
BILLERICA, MA (ONSITE)
At Wimmer Solutions, we believe care creates community. We work smart; we have built a reputation for results-oriented, innovative, business and technology solutions that help companies execute on their strategic initiatives. We have fun; we love our work. We are positive, kind, and hungry to learn. We give big; we aim to make a real impact on the causes that affect the communities we serve and build strong relationships with the dedicated volunteers and nonprofit organizations working to address them.
We are all about people and community. Since 2002, we have offered technology staffing and managed services for the greater Seattle area and throughout the United States. We focus on getting to know our clients and candidates to create lasting partnerships and ensure success.
Our client is looking for a Senior Associate, Compliance (Product Quality) who will provide scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
WHAT YOU GET TO DO
WHAT YOU BRING
Must be able to work for a US based company without requiring visa sponsorship.
COMPENSATION AND BENEFITS
MORE ABOUT WIMMER SOLUTIONS
Wimmer Solutions is proud to be an equal-opportunity employer. All applicants will be considered for employment regardless of race, color, religion or belief, age, gender identity, sexual orientation, national origin, parental status, veteran, or disability status. Wimmer Solutions is committed to achieving a diverse employee network through all aspects of the hiring process and we welcome all applicants.
If you are passionate about what you do and want to join a diverse team dedicated to diversity, equity, and inclusion in the workplace, we would love to hear from you. Get the job you have always wanted. You will join a broad team of professionals who are energized about their careers as well as their community. For more career opportunities or to refer a friend, please visit and talk to a recruiter today.
