Senior Associate Compliance

1 week ago

Billerica, United States Wimmer Solutions Full time

SENIOR ASSOCIATE COMPLIANCE - (Product Quality)

Billerica, MA (Onsite)


22622


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 who will be providing 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

  • 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.
  • Author/revise standard operating procedures (SOPs) and test methods, as required.
  • Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
  • 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.


WHAT YOU BRING

  • 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.


Must be able to work for a US based company without requiring visa sponsorship.


COMPENSATION AND BENEFITS

  • Salary range is between $100,000 to $120,000 based on experience and qualifications, as well as geographical market and business considerations.
  • +10% bonus
  • 3 weeks paid vacation
  • 401(k) match

  • Senior Associate, Compliance Specialist

    3 days ago

    Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Senior Associate, Compliance Specialist provides scientific support in the root cause analysis and closure of Out-of-Specification (OOS) investigations, Out-of-Trend (OOT) investigations, and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Quality Management...

  • Senior Associate Compliance

    7 days ago

    Billerica, United States Wimmer Solutions Full time

    SENIOR ASSOCIATE COMPLIANCE - (Product Quality)Billerica, MA (Onsite)22622At 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...

  • Senior QA Compliance Specialist

    2 weeks ago

    Billerica, Massachusetts, United States Wimmer Solutions Full time

    SENIOR ASSOCIATE, QA COMPLIANCE - APQR (ANNUAL PRODUCT QUALITY REVIEW)Location: Billerica, MA (Onsite)At Wimmer Solutions, we prioritize the importance of community and collaboration. Our commitment to delivering innovative business and technology solutions has established us as a trusted partner for organizations seeking to fulfill their strategic goals. We...

  • Senior QA Compliance Specialist

    2 weeks ago

    Billerica, Massachusetts, United States Wimmer Solutions Full time

    SENIOR ASSOCIATE, QA COMPLIANCE - APQR (ANNUAL PRODUCT QUALITY REVIEW)Location: Billerica, MA (Onsite)At Wimmer Solutions, we prioritize community and collaboration. Our commitment to delivering innovative business and technology solutions has established us as a trusted partner for organizations striving to achieve their strategic goals. We foster a...

  • Senior Associate, QA Compliance

    2 months ago

    Billerica, United States Wimmer Solutions Full time

    SENIOR ASSOCIATE, QA COMPLIANCE - APQR (ANNUAL PRODUCT QUALITY REVIEW)Billerica, MA (Onsite)22911At 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...

  • Senior Associate, QA Compliance

    2 months ago

    Billerica, United States Wimmer Solutions Full time

    SENIOR ASSOCIATE, QA COMPLIANCE - APQR (ANNUAL PRODUCT QUALITY REVIEW)Billerica, MA (Onsite)22911At 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...

  • Senior Manager, Quality Assurance and Compliance

    3 days ago

    Billerica, Massachusetts, United States Sun Pharmaceutical Industries Full time

    Job Summary**Job Title:** Senior Manager, Quality Assurance and Compliance**Job Summary:** We are seeking a highly experienced Senior Manager, Quality Assurance and Compliance to join our team at Sun Pharmaceutical Industries. The successful candidate will be responsible for ensuring the quality and compliance of our medical devices and combination products...

  • Resident Care Associate Supervisor

    2 months ago

    Billerica, United States Benchmark Senior Living Full time

    Benchmark Senior Living is looking for a Resident Care Associate Supervisor at our Billerica Crossings Community! Joining the Benchmark Senior Living team means putting your passion to work. Our associates feel a sense of belonging with the care that they provide, empowered by the open and reliable team that surrounds them. Our diverse and skilled workforce...

  • Senior Associate, Compliance

    3 months ago

    BILLERICA, United States Sun Pharma (Taro Pharma) Full time

    Job SummaryThe 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...

  • Senior Associate, QA Compliance

    3 months ago

    Billerica, United States Sun Pharma (Taro Pharma) Full time

    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...

  • Senior Associate

    3 months ago

    Billerica, United States SUN PHARMA Full time

    Job SummaryThe 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...

  • Senior Associate, QA Compliance

    3 months ago

    Billerica, United States Sun Pharma (Taro Pharma) Full time

    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...

  • Senior Associate, QA Compliance

    3 months ago

    Billerica, United States Sun Pharma (Taro Pharma) Full time

    Job SummaryThe 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...

  • Senior Manager, Quality Assurance and Compliance

    3 days ago

    Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Senior Manager, Quality Assurance and Compliance will be responsible for ensuring the quality and compliance of medical devices and combination products manufactured by Sun Pharmaceutical Industries, Inc. This includes ensuring that all medical devices meet established specifications and that the company's Quality Management System (QMS) is...

  • Senior Manager, Quality Assurance and Compliance

    1 day ago

    Billerica, Massachusetts, United States SUN PHARMA Full time

    Job SummaryThis is a senior-level position responsible for ensuring the quality and compliance of medical devices and combination products manufactured by SUN PHARMA. The ideal candidate will have a strong background in quality assurance and compliance, with experience in leading and/or supporting medical device regulatory inspections, corporate audits, and...

  • Lead QA Compliance Specialist

    2 weeks ago

    Billerica, Massachusetts, United States Wimmer Solutions Full time

    SENIOR ASSOCIATE, QA COMPLIANCE - APQR (ANNUAL PRODUCT QUALITY REVIEW)Location: Billerica, MA (Onsite)At Wimmer Solutions, we are committed to fostering a community through care and collaboration. Our reputation is built on delivering innovative, results-driven business and technology solutions that empower organizations to achieve their strategic goals. We...

  • Senior Associate, QA Compliance

    2 weeks ago

    Billerica, United States Sun Pharmaceutical Industries, Inc. Full time

    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...

  • Lead QA Compliance Specialist

    2 weeks ago

    Billerica, Massachusetts, United States Wimmer Solutions Full time

    SENIOR ASSOCIATE, QA COMPLIANCE - APQR (ANNUAL PRODUCT QUALITY REVIEW)Location: Billerica, MA (Onsite)Position ID: 22911At Wimmer Solutions, we prioritize the connection between care and community. Our commitment to excellence has established us as a leader in delivering innovative business and technology solutions that empower organizations to achieve their...

  • Sr. Associate Compliance

    2 weeks ago

    Billerica, United States Kaztronix Full time

    Sr. Associate Compliance (Product Quality) Fulltime Onsite We can Relocate We need the emphasis to be on QA Product Quality Compliant Investigations handling (PQC). End to end to close out the investigations backlog is top priority. APQR is also good to have. Job Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis...

  • Associate, QC Compliance

    3 months ago

    Billerica, United States Sun Pharma (Taro Pharma) Full time

    Job Summary The Associate Quality Control - Compliance role is a dual function role. The role is divided between QC compliance activities and QC laboratory GMP testing activities. Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating Procedures (SOPs) and works in accordance...