Engineering Structures Scimago Jobs in Lee Massachusetts Flexible

ModernaTX, Inc. seeks a Supervisor, Quality Assurance Operations for its Norwood, Massachusetts location.

Heres What Youll Do:

• On behalf of a global biotechnology company, maintain responsibility for quality oversight of clinical operations.
• Responsible for ensuring quality oversight of mRNA platform in clinical manufacturing.
• Provide real-time quality leadership and on-the-floor operational support for the clinical manufacturing team.
• Make quality decisions that may impact operations, ensuring appropriate escalation.
• Coordinate training, professional development, and growth of the Clinical Quality Assurance team.
• Monitor process operations to ensure compliance with procedures and specifications.
• Demonstrate knowledge of standard manufacturing compliance, quality disposition, and quality system review.
• Identify risks and communicate gaps for quality and GMP process/systems.
• Enforce adherence to current Good Manufacturing Practices (cGMPs), standard operating procedures (SOPs), and manufacturing documentation.
• Partner with manufacturing and support management teams to focus on site initiatives.
• Oversee and perform review of executed electronic and paper batch record documentation.
• Support product disposition.
• Supervise approximately 4 Quality Assurance Operations Associates/Specialists.

Heres What Youll Bring to the Table:

Minimum requirements:

• Requires a minimum of a Bachelors degree, or foreign equivalent, in Chemistry, Chemical Laboratory Technology, Manufacturing Engineering or a related field and 4 years of experience in the position offered, or as a Quality Assurance Specialist, Sr. Specialist, or related position.
• Alternatively, employer will accept an Associates degree in the stated fields and 5 years of experience in the stated positions.
• 4 years of experience must include:
  • Quality assurance in early and late-stage clinical products applying Good Manufacturing Practices (cGMP) and FDA guidelines;
  • Leveraging knowledge of Quality Management Systems (QMS) to review and approve deviations, change controls, and corrective and preventive actions (CAPAs);
  • Collecting, analyzing, and interpreting data related to quality metrics, defect rates, and process performance indicators; and
  • Performing risk assessments and implementing mitigation strategies.
• May telecommute up to 2 days per week.

Apply at https:///en-US/M_tx (Job ID: R17937) or email resume and cover letter to with subject line: R17937.

At Moderna, we believe that when you feel your best, you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

Were focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

TheSenior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.

This role will:

• Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
• Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
• Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
• Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
• Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
• Identify and order materials required to perform development and manufacturing
• Identify tooling and equipment required to perform development and manufacturing
• Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
• Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
• Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
• Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
• Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
• Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
• Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
• Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
• Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
• Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
• Lead/support validation activities including equipment validation and process validation
• Lead problem solving and investigate quality events related to formulation process or batch records
• Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
• Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
• Supervise, mentor and develop team members or relevant personnel across departments

This role requires:

• A minimum of three (3) years of experience in pharmaceutical research and manufacturing
• Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
• Experience in sterile manufacturing is preferred
• Experience in lyophilization and terminal sterilization techniques are a plus
• Knowledge of parenteral drug product manufacturing
• Proficient with calculation, data analysis, statistics and applied mathematics

Department/Unit:

Work Shift:

Salary Range:

Essential Duties & Responsibilities include but not limited to: 
•    Implements physician orders, administers medications, starts IVs, performs treatments, procedures and special tests, and document treatment as required by company policy and local/state/federal rules and regulations. 
•    Orders, interprets, and evaluates diagnostic tests to identify and assess patients' conditions. 
•    Assesses and evaluates patient needs for, and responses to, care rendered. 
•    Applies sound nursing judgment in patient care management decisions. 
•    Provides primary and emergency care for occupational and non-occupational injuries and illnesses. 
•    Administers over-the-counter and prescription medications as ordered. 
•    Collaborates with the nursing team to create a Plan of Care for all patients. 
•    Directs and guides ancillary personnel and maintain standards of professional nursing. 
 
Minimum Qualifications: 
•    Graduate of a professional academic nursing program in which a Diploma, Associate Degree or Baccalaureate Degree is conferred. 
•    Must hold current NYS Registered Nurse license 
•    Obtains and maintains certification in Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS), and Pediatric Advanced Life Support (PALS)  
•    Minimum of 1-3 years of clinical RN experience is required 
•    Minimum of 1 year of Telemetry or ICU experience is required 
•    Ability to improve job performance through continuing education. 
•    Possesses knowledge of quality concepts, principles, and problem-solving tools and techniques and demonstrates ability to apply in support of departmental and patient care quality improvement. 
 
The Cardiac Catheterization laboratory (Cath Lab) consists of three (3) laboratories and a fourteen (14) bay holding area. One (1) Cath Lab is equipped with high tech ultrasound and state-of-the-art Imaging and Anesthesia equipment where complex structural heart cases are performed. The Cardiac Catheterization laboratory also performs diagnostic and therapeutic procedures for the adult and pediatric patients under the supervision of our Medical Director. The staff consists of a blend of personnel including RPN, Medical Imaging Technicians and Certified Vascular Technicians. 
Some of the disease types commonly treated are: 
•    Arteriosclerotic Heart Disease 
•    Vascular Disease 
•    Peripheral Vascular Disease 
•    Congenital Heart Disease 
 
Albany Medical Center Cardiac Catheterization laboratory also has a robust Structural Heart Program where, on a weekly basis, Transcatheter Aortic Valve Replacement (TAVR) procedures and treating Left Atrial Appendage with catheter-based devices are performed in both in the Cath Lab and the Operating Room.

Thank you for your interest in Albany Medical Center!​

Albany Medical is an equal opportunity employer.

This role may require access to information considered sensitive to Albany Medical Center, its patients, affiliates, and partners, including but not limited to HIPAA Protected Health Information and other information regulated by Federal and New York State statutes. Workforce members are expected to ensure that:

Access to information is based on a “need to know” and is the minimum necessary to properly perform assigned duties. Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose. Reasonable efforts, consistent with Albany Med Center policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification.

We’re seeking dependable individuals who want to build a side income alongside their full-time work. This role offers flexible tasks you can perform outside your regular job hours. You’ll be given structured guidance and tools to identify side hustles that complement your main job, without conflict or burnout.

Responsibilities:

• Work through curated side-hustle ideas and evaluate which suit your skills and schedule

• Test and implement methods to generate extra income (e.g. remote tasks, micro-projects)

• Track your time and earnings; maintain simple reports

• Adjust your workflow and focus on the side hustles that deliver the best return

Requirements:

• Must have a full-time job already (or other main commitment)

• Reliable internet access and a device (laptop, tablet or smartphone)

• Basic organization skills and ability to work independently

• Willingness to learn and experiment

Preferred Qualities:

• Self-motivated

• Good at managing time

• Comfortable trying new things

• Able to commit a few hours each week

Benefits:

• Work on your own schedule (evenings/weekends)

• Low risk; minimal overhead

• Opportunity to scale income over time

• Support and guidance provided

We’re looking for people interested in a part-time remote opportunity to supplement their main income. This position is ideal for professionals, freelancers, and anyone who wants to improve their financial situation with flexible, manageable work.

You’ll receive access to structured resources explaining simple, effective ways to earn extra income using your existing skills and free time.

Responsibilities:

• Review step-by-step guides and apply them independently

• Choose methods that fit your experience and lifestyle

• Monitor and report your own results to measure progress

• Maintain consistency and reliability

Requirements:

• Reliable internet connection and basic computer literacy

• Strong self-motivation and time management

• Comfortable working independently

• Willingness to learn new approaches

Benefits:

• Remote and flexible schedule

• No selling or cold calling

• Practical ways to build a stable side income

• Opportunity for long-term financial growth