Senior Quality Assurance Specialist

5 days ago


Andover, United States Actalent Full time

Description

Assist with CMO batch compliance with FDA and ICH regulations and internal procedures

Handle deviations, investigation reviews and closure, and data entry

Support SOP and policy will be part of continuous improvement initiatives

Review and approve documents, including CMO Manufacturing batch records, lot disposition documentation/systems, Certificates of Analysis, deviations, investigations, and OOS in support of product release

Data entry of lot release cycle times for metrics generation

Support a state of continuous inspection readiness.

Skills

Quality assurance, CMO, batch record review, deviations, investigation, OOS investigation, Batch record, inventory cycle count, biologics, Gmp

Additional Skills & Qualifications

BS/MS in Biology discipline and 4+ years of experience in a cGMP environment, with strong knowledge of FDA, EU, ATMP, and JP regulations. Experience in setting up GMP operations

Microsoft Outlook, PowerPoint, Word, Excel, and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures

Experience Level

Expert Level

Pay and Benefits

The pay range for this position is $72.00 - $82.00

• Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Dec 30, 2024.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.



  • Andover, United States MasterCompliance LLC Full time

    Job Title: Senior Quality Assurance Start Date: ASAP Duration: 12 months Location: Andover, MA Hours per Week: 40 Position Overview: The QA Senior Associate plays a critical role in batch record review and the disposition of clinical and commercial BDS lots for Clientss RNA therapies. This position is a key member of the QA team, ensuring CMO batch...


  • Andover, United States Master Compliance Full time

    Job Title: Senior Quality AssuranceStart Date: ASAPDuration: 12 monthsLocation: Andover, MAHours per Week: 40Position Overview:The QA Senior Associate plays a critical role in batch record review and the disposition of clinical and commercial BDS lots for Clients’s RNA therapies. This position is a key member of the QA team, ensuring CMO batch compliance...


  • Andover, New Hampshire, United States Futran Tech Solutions Pvt. Ltd. Full time

    Job DescriptionFutran Tech Solutions Pvt. Ltd. is seeking a highly skilled Senior Software Quality Assurance Engineer to join our team.Estimated Salary: $120,000 - $150,000 per yearAbout the RoleWe are looking for a seasoned software quality assurance engineer with expertise in evaluating software requirements, designing and implementing test strategies, and...


  • Andover, Massachusetts, United States Defense Contract Management Agency Full time

    About UsDefense Contract Management Agency is a leading organization in the field of defense contracting, ensuring that contractors meet their contractual obligations. Our team works closely with government agencies and contractors to provide quality assurance services.


  • Andover, Massachusetts, United States RTX Full time

    OverviewAt RTX, we're pushing the boundaries of innovation and excellence in aerospace and defense. Our team is comprised of dedicated professionals who share a common goal: to create a safer, more secure world.SalaryWe offer a competitive salary range of $96,000 - $200,000 per year, reflecting our commitment to attracting and retaining top talent. Whether...


  • Andover, Minnesota, United States Watts Company Full time

    We are seeking a highly skilled Quality Assurance Engineer to join our team at Watts. As a Supplier Quality Engineer, you will play a crucial role in driving supplier improvement efforts and ensuring the highest quality standards across all sites.Key Responsibilities:Partner with Watts manufacturing sites to monitor supplier performance and implement...


  • Andover, United States Talent Groups Full time

    We are seeking a QA Senior Associate to oversee batch record review and disposition of clinical and commercial BDS lots for RNA therapies. This role ensures compliance with FDA, ICH, and internal regulations, manages deviations and investigations, and supports continuous improvement initiatives.Key Responsibilities:Review and approve CMO manufacturing...


  • Andover, Massachusetts, United States Vicor Corp. Full time

    Job Title: Electronics Manufacturing Quality Assurance EngineerOverview:Vicor Corp. is a leading manufacturer of high-quality products, and we are seeking a skilled Quality Assurance Engineer to join our team.Key Responsibilities:Implement effective quality control protocols, educate production staff, and supervise outcomes to ensure the production of...


  • Andover, United States Staffing Now Full time

    Summary / Objective The Quality Assurance Manager is responsible for overseeing the high quality delivery of our technology products and services for release via a Project or Sprint. This management role ensures we are designing, implementing, and improving testing methods with agile processes in mind and in collaboration with our overall software...


  • Andover, Massachusetts, United States Manpower Group Inc. Full time

    We are seeking a skilled Senior Mainframe SAS Conversion Specialist to join our team at Manpower Group Inc. Estimated Salary: $90,000 - $120,000 per year.Job Overview:The ideal candidate will have strong understanding of SAS programming, data manipulation, and logic, as well as in-depth experience with z/OS, COBOL, SORT, REXX, and z/OS utilities.Key...


  • Andover, New Hampshire, United States TUV Rheinland of North America Full time

    Job OverviewElevate your career as an Aerospace Lead Auditor at TUV Rheinland North America. This is a unique opportunity to utilize your expertise in quality assurance and regulatory compliance.


  • Andover, Massachusetts, United States Andover Manor Rehab & Nursing Full time

    Job Overview Andover Manor Rehab and Nursing is seeking a compassionate Senior Patient Support Specialist to provide high-quality care and support to our patients and their families.


  • Andover, Minnesota, United States Ora Full time

    Andover Eye Associates: A Premier Eye Care DestinationWe are seeking a highly skilled and experienced Senior Ophthalmic Specialist to join our esteemed team at Andover Eye Associates, a leading eye care provider in the Merrimack Valley area.About UsEstablished over 45 years ago by Dr. Mark Abelson, Andover Eye Associates has built a reputation for delivering...


  • Andover, Massachusetts, United States MILLENNIUMSOFT Full time

    MILLENNIUMSOFT is seeking a skilled Senior Human Factors Design Specialist to join our team in Andover, MA. The estimated salary for this role is around $110,000-$140,000 per year, depending on experience.Job DescriptionThe ideal candidate will have 2+ years of technical experience and a Bachelor's Degree in a technical field, preferably human factors...


  • Andover, Massachusetts, United States RTX Full time

    At RTX, we are committed to providing a dynamic and challenging environment for our interns. As a Quality Engineer intern, you will have the opportunity to acquire valuable skills and experience in quality assurance, continuous improvement, and lean methodologies.About UsWe value trust, respect, accountability, collaboration, and innovation at RTX. Our...

  • Senior Caregiver

    2 weeks ago


    North Andover, Massachusetts, United States Kind Senior Care Full time

    Job OverviewWe are seeking a compassionate and dedicated Senior Caregiver to join our team at Kind Senior Care in North Andover. As a Senior Caregiver, you will play a vital role in providing high-quality care to our seniors and enhancing their quality of life.


  • Andover, Minnesota, United States Infineon Technologies Full time

    Join a leading-edge power management company as a Senior Mixed Signal Design Verification Specialist.About Infineon TechnologiesInfineon Technologies is a world-leading provider of semiconductor solutions. We design, develop, manufacture, and market a broad range of semiconductors and semiconductor-based solutions for key markets in the automotive,...


  • Andover, United States Raytheon Technologies Full time

    Date Posted: 2024-10-22 Country: United States of America Location: MA113: Andover MA 352 Lowell Hampshir 352 Lowell Street Hampshire, Andover, MA, 01810 USA Position Role Type: Onsite At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression....


  • Andover, Massachusetts, United States RTX Full time

    Job OverviewThe Senior Manufacturing Equipment Specialist at RTX will be responsible for ensuring the availability of semiconductor production equipment by implementing corrective actions for hardware and software-related issues. This role requires a strong understanding of SPC controls, as well as experience maintaining, troubleshooting, and repairing...


  • Andover, Massachusetts, United States Manpower Engineering Full time

    We are seeking a highly skilled Senior Mechanical Engineering Specialist to join our team at Manpower Engineering. This is an exciting opportunity for a talented individual to contribute to the design, testing, and repair of industrial machinery and equipment.About the RoleThe ideal candidate will have 8+ years of experience in mechanical engineering with a...