Senior Compliance Specialist

Eurofins Scient. Devens , MA 01434

Posted 3 weeks ago

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2020, Eurofins generated total revenues of EUR 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

The Next Generation Therapeutics group is a newly formed team with a focus on using novel therapeutic modalities to deliver medicines for chronic pain and neuro degenerative disorders. The group, based at our Cambridge Innovation Center in Kendall Square, will work with internal and external partners to identify and deliver new novel therapies into patients at speed. The team is seeking experienced and inspiring scientists to join our fast-paced, interdisciplinary team as we leverage innovative RNA/oligonucleotide/gene and genomic based therapeutic modalities to enhance our portfolio.

Responsible for the execution and analysis of experiments and analytical procedures. Display a technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigate basic technical problems with instrumentation and software used during analysis. Independently performs routine scientific procedures and experiments after initial guidance and planning. Plan and prioritize concurrent experimental procedures. Integrate, compile, and tabulate data and assist supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Work under active supervision. Follow established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy. Contribute to the completion of milestones associated with specific projects

  • Performing Quality review of equipment installation, operation, and performance qualification protocols. Qualifications will be for production equipment (reactors, filters, ovens, etc.), analytical instrumentation (HPLC/UPLC, GC, etc.) and site utilities (HVAC, Purified Water, Nitrogen, etc.)

  • Performing Quality approval of executed equipment qualification protocols

  • Providing oversight of Supplier Management program and ensuring that required activities are completed

  • Assisting in gathering site Key Performance Indicators (KPIs)

  • Providing audit assistance for regulatory inspections and routine customer audits as well as performing internal audits

  • Assisting management with providing responses and CAPAs to audit observations

  • Working with other departments to develop and implement various trainings

  • Working on compliance related deviations/investigations, CAPAs and Changes as either owner or QA oversight

  • BS in a scientific discipline or equivalent with a 6+ years' experience in an FDA regulated industry; MS in a scientific discipline or equivalent with a 5+ years' experience in an FDA regulated industry

  • Experience with Quality Assurance oversight

  • Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations

  • Experience with Microsoft Office and other complex computer software

Position is full-time, Monday

  • Friday 8:00am

  • 5:00pm. Candidates currently living within a commutable distance of Devens, MA are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options

  • Life and disability insurance

  • 401(k) with company match

  • Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Compliance Specialist

Bristol Myers Squibb

Posted 4 weeks ago

VIEW JOBS 6/1/2022 12:00:00 AM 2022-08-30T00:00 At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. PURPOSE AND SCOPE OF POSITION: BMS Cell Therapy Manufacturing seeks Compliance Specialist III within Manufacturing that bring enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work collaboratively with safety and quality in mind. We are searching for enthusiastic, innovative individuals with a good understanding of good manufacturing practices to support and maintain several elements within the Quality Systems framework to ensure site compliance with GxPs and BMS policies. DUTIES AND RESPONSIBILITIES: * Supports readiness of the facility for Regulatory Inspections * Identifies, manages, and owns Corrective Actions and Preventive Actions (CAPA) * Supports internal / external audits following the annual site plan with respective reports and action items from areas impacted during the audit * Prepares, submits, and discusses reports of assigned Quality Systems status for trending and evaluation to the site management * Aligns facility Quality Systems with GMPs, Regulatory Standards and domestic requirements * Generates, reviews, and implements departmental procedures and forms to assure compliance with current practices, GMPs, and/or trends * Supports the Quality Risk Management program at the site participating in multidisciplinary teams * Develops impact assessments related to Policies and Directives implementation * Ensures the site has an internal audit program and that all system audits are conducted at a specified frequency * Evaluate functional strengths and developmental areas a team with the ability to focused on continuous improvement as it relates to compliance * Responsible for reviewing qualification and re-qualification of manufacturing related equipment and facility as the operations representative * Develop internal controls and policies to ensure that all compliance needs are met * Work closely with department SMEs to review all departmental policies for compliance alignment * Work as a liaison between Manufacturing and Quality Operations and relevant Management systems * Serve as a resource for Tech Transfer activities * Lead and train manufacturing teams to review manufacturing batch records, testing data, SOPs, Deviations, Change Controls, and Corrective and Preventative Action (CAPA). * Communicates Quality related initiatives and actions to all functional area managers * Must have the ability to challenge and make recommendations * Escalate compliance concerns to management in a timely manner * The ability to review and approve change controls as the manufacturing compliance representative * The ability to work as the functional area approver and reviewer · Maintain CAPA databases and Investigations and prepare trend reports * Ensure high levels of communication with team, support resources and management regarding issue identification and resolution * Other duties as assigned REQUIRED COMPETENCIES: * Bachelor's degree required * 5+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, cGMP knowledge, and production operations * 5+ years in a Manufacturing/Operations in a cGMP environment is required * An equivalent combination of education, experience, and training may substitute. * Cell Therapy manufacturing experience preferred. * Prior experience in a quality role preferred. * Ability to work by influencing peers and gain their cooperation; working collaboratively * Incumbents act with very limited supervision for routine activities to determine methods and procedures on new assignments * A high sense of urgency and a commitment to delivering results is essential. * Advanced time management skills, including ability to prioritize and manage expectations * Advanced proficiency in Microsoft Office * Advanced technical writing skills * Advanced knowledge of GMP manufacturing and regulations * Intermediate knowledge of qualification and validation requirements in a regulated environment * Basic presentation development and delivery skills * Ability to provide accurate estimates and effectively communicate status of deliverables * Ability to gown into Grade C and D classified environments * Must be familiar with many GMP-related aspects and systems like: * Quality Risk Management * Document and Data Governance * Monitoring and Quality Reports BMSCART VETERAN Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture. To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Bristol Myers Squibb Devens MA

Senior Compliance Specialist

Eurofins Scient.