-
Contracts & Compliance Associate
3 weeks ago
HEALTH RESOURCES IN ACTION, INC. Boston, United StatesPosition Description: Health Resources in Action, Inc. (HRiA) is a non-profit organization working to improve and reimagine public health. We connect, consult, and collaborate to solve complex challenges of access and equity in our health and social systems. Together with our par ...
-
Sr. Associate Compliance
1 week ago
Sun Pharmaceutical Industries Billerica, United StatesCOME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE · * Medical, Dental, Vision Benefits · * Health Savings Account (HSA), Flexible Spending Account (FSA) · * Prescription Drug Coverage · * Telehealth and Behavior Health Services · * Income Protection - Short Term and Lo ...
-
Sr. Associate Compliance
3 weeks ago
Kaztronix Billerica, United StatesSr. Associate Compliance (Product Quality) Fulltime Onsite · We can Relocate · Job Duties: · The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compli ...
-
Sr. Associate, Compliance
1 week ago
Sun Pharmaceutical Industries Billerica, United StatesCOME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE · * Medical, Dental, Vision Benefits · * Health Savings Account (HSA), Flexible Spending Account (FSA) · * Prescription Drug Coverage · * Telehealth and Behavior Health Services · * Income Protection - Short Term and Lo ...
-
Senior Associate, QA Compliance
2 weeks ago
Sun Pharmaceutical Industries Billerica, United StatesJob Summary · The Sr. Associate Compliance provides 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 ( ...
-
Associate Director, Global Trade Compliance
3 weeks ago
Alkermes, Inc. Waltham, United States**ASSOCIATE DIRECTOR, GLOBAL TRADE COMPLIANCE** · **JOB DESCRIPTION** · **Summary** · The Associate Director, Global Trade Compliance, is responsible for the creation, execution, and management of Alkermes' global trade strategies and policies. This role will provide leadership a ...
-
Emerson College Boston, United States**Associate Director, Athletics Compliance Coordinator** · **Join our **community** and experience **Emerson College**** · The Associate Director, Athletics, Compliance Coordinator at Emerson College is responsible for the overall management and coordination of activities at the ...
-
DentaQuest Wellesley Hills, United StatesYou are as unique as your background, experience and point of view. Here, you'll be encouraged, empowered and challenged to be your best self. You'll work with dynamic colleagues - experts in their fields - who are eager to share their knowledge with you. Your leaders will inspir ...
-
Santander Holdings USA Inc Boston, United States Full timeConsumer Compliance Senior Internal Audit AssociateBoston, United States of AmericaThe primary function of the Senior Audit Associate is to lead audit engagements and other associated audit activities with limited supervision, demonstrating a solid understanding of the business. ...
-
Compliance Associate
2 weeks ago
NextPhase Search Boston, United StatesCompliance Associate, Investments, Boston/ Hybrid (2 days per week in office, 3 remote) · About the Company/Role: Well established investment advisory based in Boston has a newly created Compliance Associate opportunity to join their growing compliance team, currently comprised o ...
-
Compliance Associate
1 week ago
Cambridge Associates LLC Boston, United StatesTHE OPPORTUNITY · Under the guidance of the Chief Compliance Officer and Compliance Director, the Compliance Associate is responsible for the coordination, ongoing development and administration of employee reporting, web-based compliance training, and anti-money laundering (AML ...
-
Receptionist
1 week ago
Life Care Center of Merrimack Valley Billerica, United States**Position Details**: · - Employment Status: Part-Time · - Shift: 4 p.m. - 8 p.m. · **Live the Mission**: · Weekend and Evening Availability Needed · **Position Summary**: · The Receptionist efficiently performs clerical support and serves as the facility's first greeter for all ...
-
Receptionist
1 week ago
Life Care Center of Merrimack Valley Billerica, United States**Position Details**: · - Employment Status: Full-Time · - Shift: 8 a.m. - 4 p.m. · **Live the Mission**: · Weekend and Evening Availability Needed · **Position Summary**: · The Receptionist efficiently performs clerical support and serves as the facility's first greeter for all ...
-
EMD Serono Billerica, United StatesWork Your Magic with us Start your next chapter and join EMD Serono. · Ready to explore, break barriers, and discover more? We know you've got big plans '" so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solut ...
-
Production Supervisor
3 weeks ago
Airgas Billerica, United StatesPosition Title: Production Supervisor - Plant · - Billerica, MA · - 1st Shift · - Minimal travel required. · The Production Supervisor is responsible for supervising the day to day activities for a segment within the industrial, specialty and medical distribution and gas filling ...
-
HR Administrator
3 weeks ago
AS&E Billerica, United StatesOverview: · Rapiscan Systems, an OSI Systems Company is seeking a temporary HR Administrator based out of Billerica, MA. · We are proud to be a trusted provider of advanced X-ray technologies for ports, borders, military, high-threat facilities and critical infrastructure all ove ...
-
Assembler Ii
2 weeks ago
Thermo Fisher Scientific Tewksbury, United States**Company Information**: · Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences ...
-
Associate Director, Legal and Compliance
1 week ago
Deciphera Waltham, United StatesCompany Description · Company Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platfo ...
-
Associate Compliance Manufacturing Analyst
3 days ago
Boeing North Charleston, United StatesAssociate Compliance Manufacturing Analyst / Assessor (Level 2) (1st Shift)Company:The Boeing CompanyJob ID: Date Posted: Location:USA - North Charleston, SCJob Description Qualifications:Boeing Commercial Airplanes (BCA) is currently seeking an Associate Compliance Manufacturing ...
-
Transportation Supervisor
5 days ago
Univar Solutions USA LLC Tewksbury, United States**A Place Where People Matter.** · Start your career journey with Univar Solutions Here you can make an impact on the world around you and accelerate your career in areas that energize and excite you. · The Transportation Supervisor is responsible for day-to-day operational activ ...
Senior Associate, Compliance - Billerica, United States - TalentBurst
Description
Senior Quality Assurance - Product ComplaintsBillerica, MA on site
PERM
This is a Senior QA role focused on product compliance and complaints for packaging, labeling, or product (OOS / OOT, deviations, investigations, APQR / APR (Annual Product Quality Review) Annual report writing .
Reports to Site Head of Compliance, and up to Site Head of Quality for Billerica.
Job Summary
The Sr.
Associate Compliance provides 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.
Area Of Responsibility
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
Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries
Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques
Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR.
Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable
Manage electronic Quality Management System (TrackWise)
Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.
Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs
Author/revise standard operating procedures (SOPs) and test methods, as required
Other duties as assigned
Physical Requirements:
Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance
Talk or hear
Close vision
Computer/office machines
Lift up to 10 lbs.
Some travel outside of company facility required
Travel Estimate:
Up to 5%
Education and Job Qualification
BS in chemistry or related scientific field
Superior internal and external customer service/people skills
Ability to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner
Experience
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 knowledge of instrumental and wet analytical chemistry
Strong knowledge of microbiology testing
Strong working knowledge of MS Office software
Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc...
Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture