What are the responsibilities and job description for the Manufacturing Trainer & Documentation Specialist position at Quanterix?
Billerica, MA
Quanterix is revolutionizing biomarker analysis to advance precision health, leveraging Simoa technology for ultra-sensitive protein detection. This transformative technology aims to enable earlier disease detection, better prognoses, and precise treatments, with goal of significantly improving quality of life and longevity. We are on a mission to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease.
To make this vision a reality, we brought together the most experienced management team, renowned scientists, industry leading investors and expert advisors, to form a collaborative ecosystem, united through the common goal of advancing the science of precision health.
Role Summary
Quanterix is looking for an experienced, and motivated Manufacturing Trainer & Documentation Specialist in Billerica, MA to join our Manufacturing team. This individual will need to be highly collaborative and capable of matrix management. They will report into the downstream Manager and primarily work with the downstream manufacturing team (not limited to that team). Responsibilities will include building out and managing the training program which includes training new hires and existing team members in support of a diverse assay menu. They will maintain training records, assess performance and measure progress of all manufacturing associates. Manufacturing Trainer & Documentation Specialist will be responsible for reviewing batch records for GDP, and GMP compliance in real time inside the manufacturing suit to identify gaps in training. Use KPI data to analyze effectiveness and lead continuous improvement strategy to enhance performance outcomes. Additional, activities will include supporting the manufacturing team in manufacturing activities to achieve critical production deadlines.
What You’ll Do
Candidate is expected to be onsite 5 days a week in Billerica, MA Must lift be able to lift 50 pounds Travel is Proficiency in the use of Microsoft office Suite, specifically Microsoft Excel and Word.
WHY YOU’LL LIKE WORKING FOR US:
Our Technology
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.
Our Commitment To Employees
At Quanterix, our values are based on: Team, Innovation, Customer and Owner.
Team: Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards
Innovation: Stay curious, experiment, create and change
Customer: Prioritize and celebrate these pioneers by doing our best to deliver on commitments
Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures.
We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible for equity, employee stock purchase plan, a performance bonus, and 1:1 financial counseling/planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day!
Diverse & Inclusive Workplace
Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.
Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Quanterix is revolutionizing biomarker analysis to advance precision health, leveraging Simoa technology for ultra-sensitive protein detection. This transformative technology aims to enable earlier disease detection, better prognoses, and precise treatments, with goal of significantly improving quality of life and longevity. We are on a mission to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease.
To make this vision a reality, we brought together the most experienced management team, renowned scientists, industry leading investors and expert advisors, to form a collaborative ecosystem, united through the common goal of advancing the science of precision health.
Role Summary
Quanterix is looking for an experienced, and motivated Manufacturing Trainer & Documentation Specialist in Billerica, MA to join our Manufacturing team. This individual will need to be highly collaborative and capable of matrix management. They will report into the downstream Manager and primarily work with the downstream manufacturing team (not limited to that team). Responsibilities will include building out and managing the training program which includes training new hires and existing team members in support of a diverse assay menu. They will maintain training records, assess performance and measure progress of all manufacturing associates. Manufacturing Trainer & Documentation Specialist will be responsible for reviewing batch records for GDP, and GMP compliance in real time inside the manufacturing suit to identify gaps in training. Use KPI data to analyze effectiveness and lead continuous improvement strategy to enhance performance outcomes. Additional, activities will include supporting the manufacturing team in manufacturing activities to achieve critical production deadlines.
What You’ll Do
- Manage the new hire training and maintaining an effective learning environment for all manufacturing teams through training and OJT reviews for all associates.
- Develop training materials (OJTs), instructional design and tools as needed to ensure effective knowledge transfer.
- Proven leadership skills including the ability to coach, assess, evaluate, develop, motivate, and empower others.
- Identifies, communicates, addresses, escalates regulatory gaps and issues to improve cGMP compliance
- Maintains the accuracy of training records to evaluates and measures training effectiveness.
- Deliver cGMP training to manufacturing staff and coordinate with area manager to ensure employee compliance with regulatory requirements.
- Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment.
- Responsible for prioritizing manufacturing schedule requirements within a fast-paced manufacturing operation with activities including but not limited to bottle/vial filling, buffer diluent formulation, reagent manufacturing
- Accurately record information and review of executed documentation
- Use of ERP software for production transactions and inventory control
- Collaborate with QA in creating, reviewing, closing batch record related quality events and implementing corrections to ensure timely product release.
- Perform other Manufacturing related duties as required
- BS in Chemistry, Biology or a Life Sciences discipline required and 3 years of relevant experience
- Strong understanding of biomanufacturing, wet lab skills, GDP and cGMP,
- Experience with training others
- Excellent communication, presentation skills, and ability to simplify complex concepts and make them accessible.
- Understanding of continuous improvement concepts
- ISO compliance
- Strong analytical and mathematical skills
- Inventory control and ERP experience
- Understanding of quality systems including but not limited to CAPAs, and NCRs.
- Experience with matrix management
Our Technology
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.
Our Commitment To Employees
At Quanterix, our values are based on: Team, Innovation, Customer and Owner.
Team: Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards
Innovation: Stay curious, experiment, create and change
Customer: Prioritize and celebrate these pioneers by doing our best to deliver on commitments
Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures.
We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible for equity, employee stock purchase plan, a performance bonus, and 1:1 financial counseling/planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day!
Diverse & Inclusive Workplace
Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.
Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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