Compliance Specialist

1 week ago

Westborough, United States Astellas Pharma Full time

Compliance Specialist Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com . Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a Compliance Specialist opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: This Compliance Specialist will perform critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization. The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts in the Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our patients. Essential Job Responsibilities: Essential Duties and Responsibilities include, but are not limited to, the following: Performs QA review of executed Manufacturing batch records, QC test records, raw material inspection records, and calibration records. Identifies and reports documentation errors and deviations from SOP or specifications in a timely manner. Tracks basic metrics on reviewed documents to support monthly reporting. Assists with the Deviation and Corrective / Preventive Action (CAPA) programs, aids investigations, and may assume investigation leader status for select deviation investigations. Helps ensure that deviation records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment. May assist with monthly metrics and continuous improvement opportunities for these programs. May assist with the Internal Audit program for the organization, serving as an assistant auditor to help ensure all aspects of the GMP organization remain compliant with Astellas procedures and domestic / international GMP regulations. Actively participates in continuous improvement opportunities to identify efficiencies and compliance improvements to benefit department operations or the organization at large. Authors (or assists in authoring) new or revised standard operating procedures (SOPs) for the QA department to satisfy new compliance requirements or improve work practices. May assist senior QA staff in oversight of contract manufacturing organizations (CMO), monitoring information requests, reviewing CMO work, and following up on other compliance items. Qualifications Required: BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Master’s degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail. Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint). Preferred: Demonstrated knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy. Working understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements. Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions and exercise sound Quality-by-Design principles. Experience presenting these outcomes to management. Specialized knowledge of any industry-related niche topics: bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc. Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc. ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.). Working Conditions: This position is based in Westborough, MA and will require on-site work. Benefits: Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks 401(k) match and annual company contribution Company paid life insurance Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions Long Term Incentive Plan for eligible positions Referral bonus program #LI-TD Category BioPharma QA Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

  • Energy Compliance Specialist

    1 week ago

    Westborough, Massachusetts, United States LG Energy Solution Michigan, Inc. Full time

    Job SummaryWe are seeking a highly skilled Energy Compliance Specialist to provide energy storage system product compliance support and deliverables for sales proposals and projects. The ideal candidate will work closely with key stakeholders, including customers, colleagues, consultants, and authorities having jurisdiction.

  • Regulatory Compliance Specialist for Raw Materials

    7 days ago

    Westborough, Massachusetts, United States Astellas Pharma Full time

    Astellas Pharma Inc., a global pharmaceutical company, is seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to join our team in Westborough, MA. As part of our Astellas Institute for Regenerative Medicine (AIRM), you will be responsible for ensuring the quality and compliance of raw materials used in the manufacture of cell...

  • Regulatory Compliance Specialist

    7 days ago

    Westborough, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time

    About Katalyst Healthcares and Life SciencesWe are a leading company in the healthcare and life sciences industry, dedicated to providing innovative solutions for our customers. Our team is passionate about delivering high-quality products that meet the strictest regulatory standards.Job SummaryWe are seeking an experienced Quality Investigator to join our...

  • Compliance Engineer

    7 days ago

    Westborough, Massachusetts, United States LG Energy Solution Michigan, Inc. Full time

    About the RoleWe are seeking a Compliance Engineer to provide energy storage system product compliance support and deliverables for sales proposals and projects.Key ResponsibilitiesSupport sales proposals through reviews and analysis of codes and standards requirements.Provide compliance support for projects and develop reviews and input for compliance...

  • Safety Specialist

    1 week ago

    westborough, United States TalentBurst Full time

    Safety Specialist/ Dangerous Goods Location: Westborough MA – ONSITE Duration: 11 months This role will be a Safety Specialist with functional area as Dangerous Goods Need one temp resource to work on developing a dangerous goods document repository. Review individual agile entries manually to verify DG requirements are met. Work on daily outbound...

  • Safety Specialist

    1 week ago

    westborough, United States TalentBurst Full time

    Safety Specialist/ Dangerous Goods Location: Westborough MA – ONSITE Duration: 11 months This role will be a Safety Specialist with functional area as Dangerous Goods Need one temp resource to work on developing a dangerous goods document repository. Review individual agile entries manually to verify DG requirements are met. Work on daily outbound...

  • Safety Specialist

    3 weeks ago

    Westborough, United States Talentburst Full time

    Safety Specialist/ Dangerous Goods Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying. Location: Westborough MA – ONSITE Duration: 11 months This role will be a Safety Specialist with functional area as Dangerous Goods Need one temp resource to work on developing a dangerous goods...

  • Safety Specialist

    3 weeks ago

    westborough, United States TalentBurst Full time

    Safety Specialist/ Dangerous Goods Location: Westborough MA – ONSITE Duration: 11 months This role will be a Safety Specialist with functional area as Dangerous Goods Need one temp resource to work on developing a dangerous goods document repository. Review individual agile entries manually to verify DG requirements are met. Work on daily outbound...

  • TalentBurst | Safety Specialist

    5 days ago

    Westborough, United States TalentBurst Full time

    Safety Specialist/ Dangerous Goods Location: Westborough MA – ONSITE Duration: 11 months This role will be a Safety Specialist with functional area as Dangerous Goods Need one temp resource to work on developing a dangerous goods document repository. Review individual agile entries manually to verify DG requirements are met. Work on daily outbound...

  • Hazardous Goods Specialist

    1 week ago

    Westborough, Massachusetts, United States TalentBurst Full time

    TalentBurst - Safety and Compliance Role Estimated Salary: $85,000 - $105,000 per year Job Description: In this pivotal role at TalentBurst, you will serve as a Safety Specialist with a focus on Dangerous Goods. Your primary responsibility will be to develop and maintain a comprehensive document repository for hazardous materials documentation. This entails...

  • Systems Support Specialist III

    2 months ago

    Westborough, United States BankTalent HQ Full time

    Overview The System Support Specialist III's role is to perform all primary responsibilities defined for System Support Specialist I and II. Provide technical support and training to System Support Specialists. Their primary responsibility is to perform system administration support for the Bank's Tier two systems and applications. The System Support...

  • Technical Systems Specialist III

    1 week ago

    Westborough, Massachusetts, United States BankTalent HQ Full time

    Overview">The Technical Systems Specialist III role requires the ability to perform all primary responsibilities defined for Technical Systems Specialists I and II. This position provides technical support and training to Technical Systems Specialists, with a primary responsibility of performing system administration support for Bank's Tier two systems and...

  • Home Health Care Specialist

    1 week ago

    Westborough, Massachusetts, United States Caretenders Full time

    About the RoleWe are seeking a highly skilled Home Health Care Specialist to join our team at Caretenders. This is a full-time role that requires providing home health visits throughout Shrewsbury, Boylston, Grafton, Millbury, Northborough, Berlin, and Westborough.Company OverviewCaretenders, part of LHC Group, fosters a culture of caring, belonging, and...

  • Home Health Care Specialist

    7 days ago

    Westborough, Massachusetts, United States Caretenders Full time

    We are seeking a skilled Home Health Care Specialist to join our team at Caretenders, a part of LHC Group. Our company is built on a culture of caring, belonging, and trust, which translates into meaningful connections with our patients, their families, and the communities we serve.The estimated salary for this role is around $65,000-$90,000 per year,...

  • Loan Servicing Specialist II

    4 days ago

    Westborough, Massachusetts, United States Middlesex Savings Bank Full time

    At Middlesex Savings Bank, we're seeking an experienced Loan Servicing Specialist II to join our team. As a senior member of our commercial lending team, you'll play a key role in ensuring timely and accurate loan servicing practices.About the RoleThis is a challenging opportunity for a highly organized and customer-focused individual with a strong...

  • Travel Rehabilitation Specialist

    1 week ago

    Westborough, Massachusetts, United States Whittier Rehabilitation Hospital Full time

    We are seeking a skilled Physical Therapist (PT) to join our team at Whittier Rehabilitation Hospital in Westborough, Massachusetts. As a Travel Rehabilitation Specialist, you will work with patients to help them recover from injuries or illnesses and regain their independence.About the JobJob Type: TravelProfession: Physical Therapist (PT)Specialty: PT-...

  • Environmental Health Safety Specialist

    2 months ago

    Westborough, United States SPECTRAFORCE Full time

    Safety Specialist Westborough, MA 0158111 months Mon-Fri 9am-5pmSERVICES TO BE PERFORMED· Identify and inform management of compliance issues, risks, and improvement opportunities through the conduct of , weekly, and monthly audits· Facilitate investigation process· Maintain required paperwork to comply and regulations· Enter Information in internal...

  • Senior Financial Reporting Specialist

    6 days ago

    Westborough, Massachusetts, United States Connectbase Full time

    About Connectbase">Connectbase is one of the nation's fastest-growing VC-funded SaaS companies, specializing in providing data-driven solutions for the connectivity industry. Our core platform, The Connected World, empowers ecosystem partners to utilize location-based insights and automation, streamlining the process of buying and selling connectivity more...

  • Environmental Health Safety Specialist

    2 months ago

    Westborough, United States SPECTRAFORCE Full time

    Safety Specialist Westborough, MA 0158111 months Mon-Fri 9am-5pmSERVICES TO BE PERFORMED· Identify and inform management of compliance issues, risks, and improvement opportunities through the conduct of , weekly, and monthly audits· Facilitate investigation process· Maintain required paperwork to comply and regulations· Enter Information in internal...

  • Loan Servicing Specialist

    4 weeks ago

    Westborough, United States BankTalent HQ Full time

    OverviewResponsibilities include performing a variety of loan servicing and processing activities in conformance with established bank policies, procedures and objectives. As a senior member of the team, serves as a knowledgeable resource to the Commercial Loan Servicing Specialist I. Performs any functions, within scope of authority and expertise, to...