TEAM YOU WILL BE JOINING
- Leader in precision engineered products
- Executive leadership team with proven success in the industry
- High growth strategy over the next 3 years
WHAT THEY OFFER YOU
- Significant opportunity to impact the organization during a time of growth and transition
- Exposure to a dynamic executive team and private equity firm
- Outstanding benefits and culture
- Ability to influence the organization to drive results
WHY THIS ROLE IS IMPORTANT
- Establish processes, using information from quoting and the process review meetings, to create routings in Visual Manufacturing through
- Part maintenance, material specification and engineering masters.
- Design and make drawings for production parts, assemblies, tooling, gages and fixtures for manufacturing and inspection.
- Check and approve operation sheets, PCR sheets and tooling drawings.
- Model and draft (as required) operation sheets and tooling drawings.
- Research deviations from planned process (trouble shooting on shop floor) and recommend and/or incorporate corrective actions.
- Review and incorporate changes from manufacturing and quality control.
- Assisting in preparing estimates for Job Proposals requested by our customers.
- Assist in establishing and implementing in-process Inspection planning.
- Work with customers and suppliers, as required, to resolve issues and establish processes.
- Review established processes with manufacturing and quality control to reduce required in-process inspection, while ensuring the quality of the process including support and active participation in the New Product Development Cycle. Work with Quality Engineers and Inspectors to develop efficient and effective quality plans.
- Support Statistical Process Control (SPC) preparation and implementation and work closely with Quality and Manufacturing personnel to analyze and improve its effectiveness.
- Support and assist in Tool Mapping and other process control methods.
THE BACKGROUND THAT FITS
- Preferred Bachelor’s degree with 5+ years of experience
- Proficient in solid modeling and drafting in CAD using NX-UniGraphics and Solidworks
AccruePartners values our contract and consulting employees. We offer a competitive benefits package to meet the diverse needs of all of our contractor and consulting employees and their family members. Here is a listing of what our company offers: 401(k) Medical, Dental, Vision, Life Insurance, Employee Assistance Program, Medical and Prescription Drug, Short and Long-Term Disability Insurance.
THE TEAM YOU WILL BE JOINING:
- Fortune 500 manufacturing and technology organization with significant investment in R&D and Innovation
- Rich history with over 150 years of significant growth and innovation
- Expanding global footprint in North America, South America, Europe and Asia
- Industry leader within all 8 divisions and leader in each
- Known for growing talent internally and promoting internally
WHAT THEY OFFER YOU:
- Culture: Highly collaborative, teamwork-oriented environment
- Growth: Make an immediate impact in this high visibility role
- Opportunity: Ability to drive change within organization with a focus on process improvement
- Stability: Strong executive leadership team investing in its talent and elevating the global footprint
WHERE THIS POSITION IS LOCATED:
- Tewksbury, MA
WHY THIS ROLE IS IMPORTANT:
- Handle incoming high order volume received via phone and email.
- Perform the full scope of customer service tasks including; problem solving, trouble shooting, negotiating and cultivating excellent relationships with customers and co-workers.
- Handle high volume of Case Management related to inquiries and orders in SalesForce.com
- Interact daily with internal/external contacts using multiple systems to ensure accurate information.
- Provide information and Accurate Order Entry/Order Management for a large customer base related to inventory, pricing, technical inquires, and shipping information.
- Initiate corrective actions to handle customer accommodations independently by using good judgment in routine cases.
- Assist with complaints processed by the Complaint team.
- Maintain and update dealer/customer profiles and confirm that the PeopleSoft notes, payment terms, carrier, and freight terms match the profile.
- Follow up with New Accounts team on necessary account set up changes.
- Responsible for ensuring 100% follow-up to customers internally and externally.
- Attend Product/Technical training as scheduled.
THE BACKGROUND THAT FITS:
- Associates degree and a minimum 3+ years of customer service experience desired Or 5+ years of call center experience. Bachelor's degree desired, background in Life Sciences preferred.
- Ability to handle high work volume (phone, case and order entry volume) in a fast-pace environment and stay calm in face of adversity.
- On time attendance.
- Excellent professional verbal and written communication skills
- Proficiency with Word, Excel, E-mail, Web.
- Can type at a 50-WPM average.
- Customer focused, detail oriented and effective problem solver who can independently seek a timely resolution.
- Ability to meet or exceed Department Metrics.
- Adaptable in a rapidly changing environment and can easily recognize areas for improvement and help facilitate forward movement.
- Experience with PeopleSoft Order Management or a comparable system.
- Experience with SalesForce.com case management.
- Call center experience.
AccruePartners values our contract and consulting employees. We offer a competitive benefits package to meet the diverse needs of all of our contractor and consulting employees and their family members. Here is a listing of what our company offers: 401(k) Medical, Dental, Vision, Life Insurance, Employee Assistance Program, Medical and Prescription Drug, Short and Long-Term Disability Insurance.
THE TEAM YOU WILL BE JOINING:
- Fortune 500 manufacturing and technology organization with significant investment in R&D and Innovation
- Rich history with over 150 years of significant growth and innovation
- Expanding global footprint in North America, South America, Europe and Asia
- Industry leader within all 8 divisions and leader in each
- Known for growing talent internally and promoting internally
WHAT THEY OFFER YOU:
- Culture: Highly collaborative, teamwork-oriented environment
- Growth: Make an immediate impact in this high visibility role
- Opportunity: Ability to drive change within organization with a focus on process improvement
- Stability: Strong executive leadership team investing in its talent and elevating the global footprint
WHERE THIS POSITION IS LOCATED:
- Tewksbury, MA
WHY THIS ROLE IS IMPORTANT:
- Coordinate, prepare or maintain regulatory filings or submissions to obtain and sustain product approval.
- Support regulatory plans for assigned products.
- Document and maintain regulatory procedures, work instructions, or policies.
- Review promotional materials, labeling, specification sheets, or test methods for compliance with applicable regulations and policies.
- Support regulatory related projects (UDI, EU MDR/IVDR, LVD, EMC).
- Conduct New Product Review using SharePoint based system.
- Participate on new product project teams and provide inputs for premarket regulatory requirements, labeling requirements, or clinical study.
- Review proposed product, label or manufacturing changes for regulatory impacts.
- Stay updated on existing and changing regulations, standards, or guidance documents.
- Support internal and external audits.
- Research and interpret regulations to apply to appropriate product lines.
- Prepare and support responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Support post-market surveillance, vigilance and field action activities.
- Compile and maintain regulatory documentation databases or systems
BACKGROUND THAT FITS:
- Bachelor’s Degree in technical specialty required (engineering, chemistry, or biology)
- 2 years of regulatory affairs or quality experience in life sciences, medical device, in vitro diagnostics or regulated industry
- Strong technical writing skills and attention to detail
- Proficient in information technology tools including electronic document management systems and Microsoft Office Applications: MS Word, Excel, PowerPoint
- Effective written and verbal communication skills across all levels of the organization
- Must be an effective communicator, and able to deliver messages through presentations, written and verbal communication
- Utilizes sound and rational problem solving and decision-making processes
- Ability to handle multiple tasks concurrently and in a timely fashion
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals
- Must display eagerness to learn and continuously improve
- Positive work attitude that supports teamwork and continuous improvement
- Experience with regulations related to medical device, IVD, or biopharma products
- Experience with FDA 21 CFR 820, ISO 13485, ISO 9001, or similar
- Previous regulatory submission experiences (FDA 510k, CE Mark, eCTD, etc)
- Familiar with UDI, EU MDR/IVDR, LVD, EMC regulations.
AccruePartners values our contract and consulting employees. We offer a competitive benefits package to meet the diverse needs of all of our contractor and consulting employees and their family members. Here is a listing of what our company offers: 401(k) Medical, Dental, Vision, Life Insurance, Employee Assistance Program, Medical and Prescription Drug, Short and Long-Term Disability Insurance.
THE TEAM YOU WILL BE JOINING:
- Industry-leading, bio-pharmaceutical company, listed top 40 of Global Innovation
- Innovator in scientific breakthroughs and has been at the frontier each decade
- Vision and passion around revolutions in biology for human health
- Committed to their team, discovery, a sense of urgency, open culture, and best in class performance
WHAT THEY OFFER YOU:
- Be a part of a committed and most forward-thinking team in their field
- Work alongside a diverse and culturally aware environment with opportunities for employee development and networking
- Year-round employee wellness programs and extensive employee health/safety programming
- Community events that promote education, learning, and wellness along with arts and cultural institutions
- Opportunity to collaborate on company-wide community service days and volunteerism
WHERE THIS POSITION IS LOCATED:
- Cambridge, MA
WHY THIS ROLE IS IMPORTANT:
- Review of event documentation such as Batch records, Exceptions, and Regulatory filings
- Production record review and Product disposition for drug substance, drug product, device assembly and finished goods
- Support design development plan including design verification and DHF deliverables
- Build and maintain Product Specification Files (PSF) for program
THE BACKGROUND THAT FITS:
- Minimum, a BS degree in life sciences, engineering or related field
- Minimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment
- To have been involved on a device development project before as QA
- Signed off on design development plan, completed design verification, approved DHF deliverables
- Good understanding of FDA and EMA regulations and guidelines
- Excellent organizational, communication, and interpersonal skills.
- Preferred Quality Drug Substance manufacture experience
- Knowledge of relevant government regulations and agency rules for labeling (CFR & EudraLex Volume 4, Annex 13)
- Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.
- Ability to accurately determine deadlines and ask for help if needed
- Detail oriented with solid problem solving acumen.
- Ability to work effectively in a team environment with great organization skills.
- Ability to independently analyze and reconcile moderate to complex issues.
- Must have demonstrated initiative and accountability in a fast paced environment.
- Excellent verbal and written communication and interpersonal skills.
- Proficient with computers and word processing software (i.e., Microsoft Office products)
AccruePartners values our contract and consulting employees. We offer a competitive benefits package to meet the diverse needs of all of our contractor and consulting employees and their family members. Here is a listing of what our company offers: 401(k) Medical, Dental, Vision, Life Insurance, Employee Assistance Program, Medical and Prescription Drug, Short and Long-Term Disability Insurance.
THE TEAM YOU WILL BE JOINING:
- Industry-leading, bio-pharmaceutical company, listed top 40 of Global Innovation
- Innovator in scientific breakthroughs and has been at the frontier each decade
- Vision and passion around revolutions in biology for human health
- Committed to their team, discovery, a sense of urgency, open culture, and best in class performance
WHAT THEY OFFER YOU:
- Be a part of a committed and most forward-thinking team in their field
- Work alongside a diverse and culturally aware environment with opportunities for employee development and networking
- Year-round employee wellness programs and extensive employee health/safety programming
- Community events that promote education, learning, and wellness along with arts and cultural institutions
- Opportunity to collaborate on company-wide community service days and volunteerism
WHERE THIS POSITION IS LOCATED:
- Cambridge, MA
WHY THIS ROLE IS IMPORTANT:
- Work actively and align with Clinical Operation/Study team to help create forecast for assigned study and program including enrollment rate.
- Support country logistics for shipping and importation, on assigned study or program.
- Monitor regularly drug expiry, and the appropriate inventory levels across assigned clinical programs.
- Support and oversight of packaging requirements for programs and/or protocols assigned
- Monitoring of enrollment, drop-out rates and actual supply need on assigned protocols and/or programs. Ensure continuous re-assessment of Project needs, on assigned programs and/or protocols
- Lead label creation and approvals process, including translations for all countries, on assigned study and/or program responsible for.
- Supports return and destruction of IMPs from sites to depots for assigned study.
- Interface with other members of the Clinical Supply Chain to provide and obtain information and to ensure on time delivery of assigned study.
- Perform inventory checks and manage inventory levels and cycle count at the vendor yearly on assigned study.
- Manage temperature excursions during transportation on assigned study
THE BACKGROUND THAT FITS:
- Experience in Clinical Supply and Pharmaceutical Development required, along with strong understanding of GMP and GCP
- Experience in Clinical Supply and Pharmaceutical Development required, along with strong understanding of GMP and GCP
- Knowledge of Import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance.
- Experienced working with third-party CMO clinical supply operations.
AccruePartners values our contract and consulting employees. We offer a competitive benefits package to meet the diverse needs of all of our contractor and consulting employees and their family members. Here is a listing of what our company offers: 401(k) Medical, Dental, Vision, Life Insurance, Employee Assistance Program, Medical and Prescription Drug, Short and Long-Term Disability Insurance.
THE TEAM YOU WILL BE JOINING:
- Industry-leading, bio-pharmaceutical company, listed top 40 of Global Innovation
- Innovator in scientific breakthroughs and has been at the frontier each decade
- Vision and passion around revolutions in biology for human health
- Committed to their team, discovery, a sense of urgency, open culture, and best in class performance
WHAT THEY OFFER YOU:
- Be a part of a committed and most forward-thinking team in their field
- Work alongside a diverse and culturally aware environment with opportunities for employee development and networking
- Year-round employee wellness programs and extensive employee health/safety programming
- Community events that promote education, learning, and wellness along with arts and cultural institutions
- Opportunity to collaborate on company-wide community service days and volunteerism
WHERE THIS POSITION IS LOCATED:
- Cambridge, MA
WHY THIS ROLE IS IMPORTANT:
- Work actively and align with Clinical Operation/Study team to help create forecast for assigned study and program including enrollment rate.
- Support country logistics for shipping and importation, on assigned study or program.
- Monitor regularly drug expiry, and the appropriate inventory levels across assigned clinical programs.
- Support and oversight of packaging requirements for programs and/or protocols assigned
- Monitoring of enrollment, drop-out rates and actual supply need on assigned protocols and/or programs. Ensure continuous re-assessment of Project needs, on assigned programs and/or protocols
- Lead label creation and approvals process, including translations for all countries, on assigned study and/or program responsible for.
- Supports return and destruction of IMPs from sites to depots for assigned study.
- Interface with other members of the Clinical Supply Chain to provide and obtain information and to ensure on time delivery of assigned study.
- Perform inventory checks and manage inventory levels and cycle count at the vendor yearly on assigned study.
- Manage temperature excursions during transportation on assigned study
THE BACKGROUND THAT FITS:
- Experience in Clinical Supply and Pharmaceutical Development required, along with strong understanding of GMP and GCP
- Experience in Clinical Supply and Pharmaceutical Development required, along with strong understanding of GMP and GCP
- Knowledge of Import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance.
- Experienced working with third-party CMO clinical supply operations.