Quality Assurance Compliance Specialist
Quality assurance specialist job in Westborough, MA
The Compliance Specialist CMC, Quality Assurance will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory Submissions at Client. The successful candidate will foster data integrity, quality and compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts at Client to help ensure high quality standards and value delivery for our patients.
Essential Duties and Responsibilities include, but are not limited to, the following:
Performs QA review of executed development studies intended for regulatory submissions, included but not limited to draft batch records, analytical test records, and calibration records to ensure Developmental studies are conducted and data collected in compliance with approved protocols, appropriate Corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards. Identifies and reports documentation errors and deviations from Protocols, SOPs or specifications in a timely manner.
Responsible for communicating QA review, audit results and reporting.
Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence.
Qualifications:
BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
Quality System Specialist / Senior Quality System Specialist
Quality assurance specialist job in Woburn, MA
Department: Quality Assurance
Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
The Quality System Specialist / Senior Quality System Specialist plays a key role in supporting and enhancing Vaxess Technologies' Quality Management System (QMS) to ensure compliance with applicable GMP/GLP standards. This position focuses on maintaining robust electronic quality systems, managing controlled documentation, and supporting the integration of new processes and applications.
Key Responsibilities:
Quality System and Computerized System Oversight
Support quality oversight for computerized systems, including QMS implementation, configuration, validation, and data migration activities.
Assist in launching new or enhanced system functionalities and communicating updates or user guidance to ensure effective adoption.
Collaborate with internal stakeholders and system vendors to ensure integrated processes across modules (Document Control, Training, Equipment, and Material Management).
Troubleshoot and resolve user issues as needed.
Documentation and Record Management
Manage the full lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival within the electronic document management system (EDMS).
Ensure that controlled documents, such as SOPs, batch records, and specifications, are accurate, current, and compliant with regulatory and internal requirements.
Coordinate document workflows with cross-functional teams to ensure timely completion and alignment with procedural requirements.
Author or revise SOPs, forms, and work instructions supporting quality system and GMP operations.
Training and Compliance Support
Provide training and day-to-day support to employees on document control and system processes.
Serve as a subject matter expert (SME) for document control and computerized systems during internal and external audits and inspections.
Support tracking and reporting of quality metrics (e.g., training completion, document cycle time, CAPA effectiveness) to drive continual improvement.
Qualifications:
Bachelor's degree in Life Sciences, Engineering, or a related discipline preferred; equivalent work experience considered.
2-5 years of experience in a GMP, GLP, or GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry).
Experience with electronic quality management systems (e.g., Enzyme, Greenlight Guru, Veeva, MasterControl, etc.) is strongly preferred.
Familiarity with relevant regulations and standards (21 CFR Parts 210/211/11/820; ISO 9001/13485).
Excellent attention to detail, organization, and communication skills; ability to manage multiple priorities in a dynamic environment.
Collaborative, proactive, and adaptable work style aligned with a fast-paced, innovation-driven company.
Vaxess, a venture-backed life sciences company, is building a team of exceptional people to rapidly advance products on its microneedle array platform. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CV/resume to
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Senior Compliance Trade Specialist
Quality assurance specialist job in Waltham, MA
Masis Staffing is seeking a contract to hire
Senior Compliance Trade Specialist
for a role in Waltham, MA.
This is a Contract to Hire Opportunity
.
This is a hybrid role, requiring you to be onsite 1-2 days a month.
$35-$45/HR
REQUIRED QUALIFICATIONS:
BA/ BS Business Degree/Business Administration/Supply Chain. Relevant experience may be considered as substitution for degree.
4+ years related experience required * Proficient in Classification (EAR/CCL, ITAR/USML), Recordkeeping, Valuation, Country of Origin and other areas.
Proficient with the Microsoft Office platform, NetSuite, Visual.
Knowledge of U.S. and Canadian Trade Regulations Electronic Export Information (EEI) filing.
Proficient with the Microsoft Office platform. Must be able to analyze large amounts of data using Excel.
PREFERRED QUALIFICATIONS:
ITAR/EAR and related regulatory knowledge.
Familiarity with restricted party screening.
Knowledge of U.S. Trade Regulations including regulations applicable to BIS, OFAC, DDTC, CFR 19, CFR 15 DDTC and the U.S. Census.
Excellent verbal and written communication skills.
Must be a highly organized, self-managed individual who works independently with the ability to support others and work in a fast-paced environment.
Ability to analyze complex situations, identify gaps in processes and operationalize trade compliance guidelines
Responsibilities:
The Senior Specialist, Trade Compliance- Export, will support EVIDENT business operations by executing the company's export policies and procedures with a specific emphasis on Export Administration Regulations (EAR), and the International Traffic in Arms Regulations (ITAR) classifications. This person works with the Trade Compliance organization to determine export classification assessments, and country of origin determination to include but not limited to RPS screening and recordkeeping. Periodically support import team activities as needed. Work cross-functionally with EVIDENT team members around the globe to ensure compliance with U.S. and international import regulations.
Job Duties:
Collaborate with sourcing, engineering and other departments to correctly assess jurisdiction classification, Country of Origin under the ITAR/EAR regulations.
Analyze, research and assign the appropriate, Commerce Control List (CCL) and United States Munitions List (USML) classifications and Country of Origin for all Olympus materials.
Maintain required records according to regulatory requirements and company policy.
Conduct, assess and monitor RPS screening database.
Apply for appropriate Export Licenses as required.
Assist in audits and close out of export and EEI activity.
Update and maintain records for the Trade Compliance team.
Develop Work Instructions for both export and import processes.
Assist in documentation/data gathering requirements related to export import matters to include, assisting in research and preparation of documentation in response to government agencies inquiries.
Develop reports and metrics related to KPI's for the Trade Compliance team.
Manage and maintain updates to the Export and HTS classifications, in the ERP systems, to include but not limited to management of Teams files and folders.
Other duties as assigned
Comments/Special Instructions
This is a hybrid role and is expected to be on site 1 to 2 days per month, more if needed.
Must be able to meet ITAR requirement
Looking for someone that understands Export Fundamentals
Biomedical Education QA Engineering Coordinator
Quality assurance specialist job in Boston, MA
Site: The Brigham and Women's Hospital, Inc.
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
Job Summary
Summary
Responsible for building, providing, coordinating, and, facilitating comprehensive training and education on the use, maintenance, and troubleshooting of biomedical equipment to BME technical staff.
Does this position require Patient Care? No
Essential Functions
- Develop, deliver, coordinate, and facilitate training programs on the use and maintenance of biomedical equipment, including but not limited to diagnostic, therapeutic, and monitoring devices.
-Develop and update training materials, user guides, and standard operating procedures (SOPs) for various biomedical devices and technologies. Ensure training programs are aligned with the latest industry standards, safety regulations, and healthcare protocols.
-Provide and facilitate practical, hands-on training sessions, demonstrating how to properly set up, operate, and troubleshoot biomedical equipment. Ensure participants achieve competency in equipment use to enhance patient outcomes.
-Stays up to date on new technologies, product updates, and advancements in biomedical engineering.
-Ensure that all training content adheres to healthcare regulations, safety standards, and compliance guidelines (e.g., FDA, OSHA).
-Evaluate the effectiveness of training programs through assessments, feedback, and observation. Identify areas for improvement and adjust training programs to ensure participants meet required proficiency levels.
-Work closely with biomedical engineering teams, medical device manufacturers, and technical staff to ensure smooth integration of biomedical equipment into healthcare operations.
Qualifications
Education
Bachelor's Degree Biomedical Engineering required or Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
Yes
Licenses and Credentials
Experience
Experience in biomedical equipment or other closely related role 3-5 years required and Experience in training, staff development, or other related role 1-2 years preferred
Knowledge, Skills and Abilities
- Strong technical understanding of biomedical equipment, such as diagnostics, patient monitoring, and therapeutic devices.
- Excellent communication and presentation skills, with the ability to convey complex technical concepts to non-technical audiences.
- Proficiency in Microsoft Office Suite (PowerPoint, Word) and familiarity with training software or learning management systems (LMS).
- Problem-solving skills with an ability to troubleshoot and resolve technical issues in real time during training sessions.
Additional Job Details (if applicable)
Physical Requirements
Standing Frequently (34-66%)
Walking Frequently (34-66%)
Sitting Occasionally (3-33%)
Lifting Frequently (34-66%)
Carrying Frequently (34-66%)
Pushing Occasionally (3-33%)
Pulling Occasionally (3-33%)
Climbing Rarely (Less than 2%)
Balancing Frequently (34-66%)
Stooping Occasionally (3-33%)
Kneeling Occasionally (3-33%)
Crouching Occasionally (3-33%)
Crawling Rarely (Less than 2%)
Reaching Frequently (34-66%)
Gross Manipulation (Handling) Frequently (34-66%)
Fine Manipulation (Fingering) Frequently (34-66%)
Feeling Constantly (67-100%)
Foot Use Rarely (Less than 2%)
Vision - Far Constantly (67-100%)
Vision - Near Constantly (67-100%)
Talking Constantly (67-100%)
Hearing Constantly (67-100%)
Remote Type
Hybrid
Work Location
100 Blossom Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$92,102.40 - $134,056.00/Annual
Grade
7
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
EEO Statement:
The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
Auto-ApplyQuality Assurance Specialist II, Batch Records Raw Materials
Quality assurance specialist job in Milford, MA
About this opportunity : In this position you will support day-to-day QA Operations activities such as batch record review, release of raw materials, review of AA and HVAC reports, customer corrections and following cGMP practices and guidelines. This role serves as a key quality interface between operational teams and quality oversight functions.
Key Responsibilities:
Review and verify raw material documentation (e.g., Certificates of Analysis, Certificates of Compliance, and material specifications) for compliance with internal and regulatory requirements.
Responsible for reviewing, approving, scanning, and binding quality records/batch records, and raw materials records.
Responsible for knowledge of SAP system for release/rejection of raw materials.
Maintains spreadsheets for the review cycles of quality documents.
Interact /communicate with various department such as Manufacturing, Supply Chain and Quality Control.
Coordinate corrections for quality documents internally and externally (e.g., client comments)
Provide assistance during cGMP compliance inspections of the Milford facility. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections.
Attend daily QA meetings.
Support Senior/Lead Specialists.
Gather/support corrections, quality metric reports to executive management.
Provide strong link/communication between the QA function/activities with all other departments at the Milford site.
Support Material Review Board (MRB) and labeling of raw materials (as required).
Support Raw material re-evaluation process.
Assist in customer documentation requests.
Perform walk-through of manufacturing suites (as required).
Help with internal audits of all GMP departments.
Assist in deviation and investigation follow-up by coordinating data collection and document retrieval.
Contribute to inspection readiness activities, document control harmonization, and trending initiatives in collaboration with QA Systems.
Actively participate in continuous improvement efforts related to QA operations, document lifecycle management, and process ownership.
Required Skills/Abilities:
The job requires a BS/BA in science or equivalent work experience of at least 2 years' experience in either Production or Quality Assurance.
Provide sound decision-making and guidance on all aspects of batch record review and raw material release.
Provide strong link/communication between the QA Operations and QA Projects Departments.
Interface with Manufacturing, QC, Warehouse, and Supply Chain to ensure timely and compliant material release and disposition activities.
Must be able to gown up and enter Manufacturing suites.
The annualized salary for this position is $65,600.00 - $79,800.00.
Marketing QA Specialist
Quality assurance specialist job in Boston, MA
At DraftKings, AI is becoming an integral part of both our present and future, powering how work gets done today, guiding smarter decisions, and sparking bold ideas. It's transforming how we enhance customer experiences, streamline operations, and unlock new possibilities. Our teams are energized by innovation and readily embrace emerging technology. We're not waiting for the future to arrive. We're shaping it, one bold step at a time. To those who see AI as a driver of progress, come build the future together.
The Crown Is Yours
As a Marketing QA Specialist on the Growth Marketing Team, you'll oversee the daily operations of a high-performing QA function that supports both our CRM and growth initiatives. You'll guide a team of junior and senior QA Associates, streamline workflows, integrate AI-driven tools, and ensure quality standards are upheld across every customer-facing campaign. This is your opportunity to shape the future of how we scale marketing QA with speed, accuracy, and innovation.
What you'll do as a Marketing QA Specialist
Oversee daily team operations and maintain coverage across QA boards in line with channel volume, seasonal trends, and high-impact events.
Partner with senior associates to assign team members based on capacity, skill set, and business needs.
Conduct weekly 1:1s with junior team members to support development and track progress against OKRs.
Lead the rollout of AI-powered tools for QA workflows-from research and testing to implementation and training.
Track and analyze monthly performance metrics and prepare quarterly insights for senior leadership.
Keep all SOPs up to date to reflect new tools, systems, or process updates.
Identify areas for improvement across tools, documentation, and communication to scale the QA program.
Help ensure consistency across service-level agreements, systems, and team standards.
What you'll bring
At least 3 years of experience in operations, team coordination, or marketing program management.
Proven ability to manage workflows, schedules, and resource allocation across multiple team members.
Experience mentoring or managing junior talent with a focus on growth and accountability.
Proficiency in marketing tools such as Airtable, Jira, Braze, Wrike, and Tableau.
Strong analytical mindset and ability to build and present performance reports.
A systems-thinking mindset and comfort navigating evolving processes.
Curiosity and initiative when it comes to implementing AI or automation tools.
Excellent communication and cross-functional collaboration skills.
Join Our Team
We're a publicly traded (NASDAQ: DKNG) technology company headquartered in Boston. As a regulated gaming company, you may be required to obtain a gaming license issued by the appropriate state agency as a condition of employment. Don't worry, we'll guide you through the process if this is relevant to your role.
The US base salary range for this full-time position is 90,300.00 USD - 112,800.00 USD, plus bonus, equity, and benefits as applicable. Our ranges are determined by role, level, and location. The compensation information displayed on each job posting reflects the range for new hire pay rates for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific pay range and how that was determined during the hiring process. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Auto-ApplyBiomedical Education QA Engineering Coordinator
Quality assurance specialist job in Boston, MA
Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
Job Summary
Summary
Responsible for building, providing, coordinating, and, facilitating comprehensive training and education on the use, maintenance, and troubleshooting of biomedical equipment to BME technical staff.
Does this position require Patient Care? No
Essential Functions
* Develop, deliver, coordinate, and facilitate training programs on the use and maintenance of biomedical equipment, including but not limited to diagnostic, therapeutic, and monitoring devices.
* Develop and update training materials, user guides, and standard operating procedures (SOPs) for various biomedical devices and technologies. Ensure training programs are aligned with the latest industry standards, safety regulations, and healthcare protocols.
* Provide and facilitate practical, hands-on training sessions, demonstrating how to properly set up, operate, and troubleshoot biomedical equipment. Ensure participants achieve competency in equipment use to enhance patient outcomes.
* Stays up to date on new technologies, product updates, and advancements in biomedical engineering.
* Ensure that all training content adheres to healthcare regulations, safety standards, and compliance guidelines (e.g., FDA, OSHA).
* Evaluate the effectiveness of training programs through assessments, feedback, and observation. Identify areas for improvement and adjust training programs to ensure participants meet required proficiency levels.
* Work closely with biomedical engineering teams, medical device manufacturers, and technical staff to ensure smooth integration of biomedical equipment into healthcare operations.
Qualifications
Education
Bachelor's Degree Biomedical Engineering required or Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
Yes
Licenses and Credentials
Experience
Experience in biomedical equipment or other closely related role 3-5 years required and Experience in training, staff development, or other related role 1-2 years preferred
Knowledge, Skills and Abilities
* Strong technical understanding of biomedical equipment, such as diagnostics, patient monitoring, and therapeutic devices.
* Excellent communication and presentation skills, with the ability to convey complex technical concepts to non-technical audiences.
* Proficiency in Microsoft Office Suite (PowerPoint, Word) and familiarity with training software or learning management systems (LMS).
* Problem-solving skills with an ability to troubleshoot and resolve technical issues in real time during training sessions.
Additional Job Details (if applicable)
Physical Requirements
* Standing Frequently (34-66%)
* Walking Frequently (34-66%)
* Sitting Occasionally (3-33%)
* Lifting Frequently (34-66%)
* Carrying Frequently (34-66%)
* Pushing Occasionally (3-33%)
* Pulling Occasionally (3-33%)
* Climbing Rarely (Less than 2%)
* Balancing Frequently (34-66%)
* Stooping Occasionally (3-33%)
* Kneeling Occasionally (3-33%)
* Crouching Occasionally (3-33%)
* Crawling Rarely (Less than 2%)
* Reaching Frequently (34-66%)
* Gross Manipulation (Handling) Frequently (34-66%)
* Fine Manipulation (Fingering) Frequently (34-66%)
* Feeling Constantly (67-100%)
* Foot Use Rarely (Less than 2%)
* Vision - Far Constantly (67-100%)
* Vision - Near Constantly (67-100%)
* Talking Constantly (67-100%)
* Hearing Constantly (67-100%)
Remote Type
Hybrid
Work Location
100 Blossom Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$92,102.40 - $134,056.00/Annual
Grade
7
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
EEO Statement:
The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
Auto-ApplyMailroom Quality Assurance Associate
Quality assurance specialist job in Massachusetts
Mailroom Quality Assurance Associate needs 1+ years experience required.
Mailroom Quality Assurance Associate requires:
3rd shift
· Minimum of a high school diploma (or GED) is required, but advanced degree is desired. · Experience of working with teams in a collaborative environment
· Must possess excellent communications skills (i.e., interpersonal, written, verbal and presentation)
Mailroom Quality Assurance Associate duties:
Maintains Quality Management System (QMS) programs and initiatives.
· Provides critical information for audits and reviews/analyzes data and documentation.
· Maintains all required documentation to meet the required security compliance standards and to meet audit control standards, Standard Operating Procedures (SOP), Forms, spreadsheets, data analytics.
· Performs and documents required monthly user reviews for associates access, both data and physical and additional security requirements to meet control objectives.
· Works closely with Operations.
· Identifies the interface of key activities within and between the functions of the organization.
· Monitors all aspects of required Corporate directed training to ensure completion target dates are met and meets targets for all other duties as assigned.
Quality Assurance Coordinator
Quality assurance specialist job in Worcester, MA
The Quality Assurance Coordinator supports the facility Compliance Program by assisting the Executive Director with the initiatives designed to adhere to the standards, regulations and requirements issued by accreditation organizations and state/federal agencies. The role also collaborates with the field and Legal department in responding to escalated medical records requests made to the Company.
JOB RESPONSIBILITIES
* Coordinates, with assistance, key components of the Compliance Program that are designed to meet the requirements or recommendations of Federal and State regulatory agencies.
* Supports the field compliance team in managing the day-to-day operations of the enterprise-wide Compliance Program, including assisting with the documentation needed to accompany state licensure applications and the voluntary accreditation process.
* Creates reports for Compliance meetings.
* Develops and maintains critical organizational systems designed to meet deadlines issued by regulatory bodies, organizes key policies and procedures and responds to escalated medical record requests.
* Interfaces with client satisfaction survey vendor and Marketing department to develop reports to be used in Performance Improvement initiatives throughout the organization.
* Sort, alphabetize and scan client documents accurately in client electronic medical records.
* Review medical records for completeness, assemble records into standard order, and file records in designated areas according to applicable alphabetic and numeric filing systems.
* Review files and documents in clients' electronic medical charts for accuracy.
* Respond to requests for information from files according to established policies and procedures.
* Maintain alphabetic filing system by organizing client records on shelves to ensure records are readily accessible by all departments.
* Respond to inquiries from Clinical staff pertaining to medical records. Comply with federal HIPAA regulations and practice policies for the privacy and security of client information; explain the law and our privacy policy to clients as needed; maintain appropriate documentation of access to medical records.
JOB QUALIFICATIONS
* Minimum of three (3) years of work experience in a compliance or quality assurance support role.
* Experience handling sensitive information with complete confidentiality.
* Thorough understanding of the importance of confidentiality and non-disclosure according to the general standards set forth by HIPAA.
* Knowledge of basic data processing procedures.
* Minimum 6 months medical records experience preferred.
* Knowledge of medical record keeping principles and practices and electronic medical records preferred.
* Knowledge of medical terminology, standard nomenclature and classification of diagnoses and operations preferred.
* Must meet pre-employment and maintain all applicable state and job-related guidelines for background screening, fingerprinting, drug testing, health screening, DMV, Insurance, CPR/Basic First Aid and license/credential verifications.
* Strong verbal and written communication skills.
* Advanced Excel skills including pivot tables and formulas.
* Experience maintaining policy and procedure documentation.
Quality Assurance Coordinator
Quality assurance specialist job in Waltham, MA
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Abcam, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
Progress happens together
At Abcam, we believe the scientific community goes further, faster when we go there together. That's why we work with life scientists to provide biological reagents and solutions that enable faster breakthroughs in critical areas like cancer, neurological disorders, infectious diseases and metabolic disorders. Our talented team of over 1,400 colleagues worldwide is our greatest asset. By applying our expertise and pushing boundaries, together we strive to better serve our customers, strengthen our impact across our industry, and ultimately our positive impact on society.
Learn about the Danaher Business System which makes everything possible.
The Quality Assurance Coordinator is responsible for managing controlled quality documentation within an electronic QMS, supporting internal audits, and ensuring compliance with established quality standards. This role involves reviewing and approving key quality documents, monitoring supplier performance, and driving continuous improvement initiatives across processes and products. Additionally, the coordinator facilitates quality forums, supports training programs, and assists in maintaining a strong culture of quality and safety throughout the organization.
This position reports to the Quality Assurance Manager and is part of the Regulatory Affairs and Quality Assurance department located in Waltham Massachusetts and will be an on-site role.
In this role, you will have the opportunity to:
* Manage controlled quality documentation through the electronic QMS and ensure timely review and approval of key records such as Certificates of Analysis and batch manufacturing documents.
* Support internal audits, non-conformance investigations, and corrective/preventive actions to maintain compliance with the Quality Management System and drive continuous improvement.
* Assist with quality training programs, supplier performance monitoring, and cross-functional forums to promote a strong quality culture and adherence to health and safety policies.
The essential requirements of the job include:
* A degree in biological sciences, or equivalent professional certification in quality management systems.
* 2 years' experience of working within the Life Science or Medical Device Industry.
* A working knowledge of quality systems such as ISO 9001:2015 and ISO 13485: 2016.
It would be a plus if you also possess previous experience in:
* Operational Excellence programs like LEAN, Six Sigma, Toyota Production Systems or Danaher Business Systems
* Audit certifications for ISO 9001 or ISO 13485.
Abcam, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range OR the hourly range for this role is $35/hour. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit ****************
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:************** or applyassistance@danaher.com.
Assurance Associate
Quality assurance specialist job in Dedham, MA
As an Assurance Associate at Waldron Rand, you will be responsible for applying basic areas of GAAP as necessary and documenting, validating, testing and assessing various control systems. This position may also be involved in compilations, reviews and agreed-upon procedure engagements. You will work closely alongside Partners, Managers, and Senior Associates as a member of the engagement team.
Responsibilities
Skillfully and accurately perform audits
Review procedures as assigned by supervisors
Prepare audit work papers and adjusting trial balances
Analyze and compile financial statements into a written report to be presented to clients and coworkers
Continuously foster relationships with coworkers and clients
Qualifications
Bachelor's degree in Accounting or a related business field
0-3 years' experience
Must be proficient in Microsoft Excel
Self-starter that can manage their day and manage the results of the project
Exceptional verbal and written communication and interpersonal skills
Relevant work experience (e.g. internships, summer positions, school jobs)
Demonstrated leadership, problem solving, and strong business acumen
Ability to prioritize tasks, work on multiple assignments, and manage ambiguity
Ability to work both independently and as part of a team with professionals at all levels
About Waldron Rand
Success starts here. Hiring outstanding people is essential to providing the best results for our clients. We take responsibility for fostering talent, building knowledge and skill, and ensuring that professional development is happening every day. Our team-service approach maximizes learning opportunities and exposes staff to the wide-range of accounting, auditing, tax, and business advisory services. The Firm's practice of having a member of the leadership team actively involved in all engagements ensures that staff members work directly with leadership from day one, gaining unsurpassed training, experience, and visibility.
Waldron Rand is the oldest practicing accounting firm in the country. The Firm's successful continuity is a direct result of our people and our commitment to continual advancement of the industry. Our progressive culture invites creativity and innovation into the practice of public accounting. It is the union of our technical skill and forward thinking that makes Waldron Rand a great place to work. Join Us.
Audit & Assurance Associate
Quality assurance specialist job in Woburn, MA
Reports To | Supervisor
A&A Seniors and above within the A&A Team
Summary of Job Function
At LGA, our primary focus is on our people. As an Associate in LGA's Audit and Assurance service line, you will work extensively on audits, reviews, and compilation engagements in various owner-managed businesses.
Essential Job Duties:
Open to gaining experience and knowledge to plan and perform audits, reviews, and compilation engagements in various owner-managed businesses for a number of different industries
Able to become familiar with accounting and auditing procedures in accordance with firm standards in an accurate, thorough, and timely manner
Prepares financial statements and develops proper techniques to prepare appropriate work papers
Able to obtain an understanding of various clients' accounting systems and processes.
Able and willing to meet business and client deadlines
Maintains flexibility to manage multiple client projects and multiple engagement teams, especially during busy seasons which includes traveling to client sites
Ongoing commitment to continuing education and professional growth
Demonstrates the ability to interact and communicate confidently and concisely with various levels of firm management in both written and verbal form
Demonstrates understanding of accounting principles and auditing procedures and is increasingly able to apply this knowledge without direct instruction
Demonstrates a clear understanding of the Firm's Risk-Based Audit approach and the impact of efficiency in assigned areas
Reads, understands and assists in the preparation of financial statements or reports in assigned audit areas; ensures that audit documentation is clear and concise. Assists in preparation of financial statements or their attest reports in assigned audit areas
Demonstrates the ability to accurately identify and document basic accounting systems and controls in assigned areas
Demonstrates the ability to identify potential audit issues and communicates them in a timely manner to the engagement team. Beginning to perform effective audit and accounting research; is proactive in researching items prior to approaching team members for assistance
Proficiency in CCH Engagement, CCH Tax, Microsoft Office Suite, and other firm technologies to enhance client service and efficiency.
Apply industry knowledge to multiple clients and consider issues from various perspectives.
Education and Experience:
Bachelor's degree in Accounting, Taxation, or a related field
Master's degree in Accountancy or Tax or a plan to pursue preferred
CPA or EA certification or a plan to pursue preferred
0-2 years' experience in a related field
Required Qualifications:
Proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.).
Experience with the CCH Suite of Products (ProSystem fx Tax, Engagement, Document, Portal) is a plus.
Experience with DataSnipper is a plus.
Comfortable working in a technology-driven, paperless environment.
Strong organizational skills, detail oriented, and able to manage multiple deadlines.
Ability to work with a sense of urgency and be flexible in tasks and time while managing your workload with adjustments to your schedule especially during peak workload times in the service line.
Contributes to a positive and collaborative work environment by upholding the firm's vision and values.
Respect for compliance and confidentiality.
Work Environment and Special Physical Demands
The work environment characteristics described here are representative of those an employee encounters while performing the
essential functions
of this job. A reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This job is performed in an office setting, indoors, and at times travel to one of the other firm locations is required.
Dexterity of hands and fingers to operate a computer keyboard, mouse, and other machines.
While performing the duties of this Job, the employee is regularly required to stand and walk.
Talk or hear.
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
Overtime may be required to meet project deadlines and support the team during traditional peak seasons.
LGA is committed to providing an equal opportunity and reasonable accommodation for people with disabilities. If you require a reasonable accommodation to complete an application, interview, or otherwise participate in the recruiting process, please email us at ***************.
Service Line: Internal, A&A Team
Function: Billable
FLSA Status: Exempt
Location: Any LGA office (Woburn, MA, Salem, NH or Chestnut Hill, MA) or remote
Employment Type: Entry Level
Degree Required: Yes
Direct Reports/Supervisory Responsibility: None
Travel: Occasionally between LGA offices and client sites
PT Quality Assurance Associate
Quality assurance specialist job in Boston, MA
At Food Lion, Associates are the most important assets to our organization. We want associates to have meaningful careers full of variety and challenges. Each associate contributes to the overall success of Food Lion, and in return, we strive to provide all associates with a fulfilling work experience and reward performance and commitment. We are committed to the professional development of our associates through on-the-job learning opportunities and training.
Provide our customers with a clean, safe, inviting place to shop by maintaining standards in accordance with the standard practice manual. Minimize shrink through proper utilization of standard practice.
Duties and Responsibilities:
Maintain an atmosphere of enthusiastic customer awareness with primary emphasis on fast, friendly, and accurate customer service to create a positive shopping experience
Courteous and helpful to other associates
Sweep and clean floors on nights with no scheduled vendor services
Weekly cleaning of Produce, Market and Deli Departments
Clean and organize the store mop room
Find more efficient ways to do the job and seek to reduce costs and improve labor productivity
Follow QA daily check list and sanitation standards set by Food Lion
Follow current Standard Practices regarding cleanup of Hazardous Waste product
Maintain a complete understanding of and adherence to company guidelines, policies and standard practice
Understand and follow Food Safety and Workplace Safety guidelines and procedures
Observe and correct all unsafe conditions that could cause associate or customer accidents
Report all associate and customer accidents in accordance with established Food Lion procedures to the Manager on Duty
Ensure compliance with local, state and federal regulations
Wear the Food Lion uniform complete with name badge, when on duty, has a neat and clean appearance while adhering to the Food Lion dress code
Successfully complete Computer Based Training (CBT), Training Packet and Training Aid courses
Perform all other duties as assigned
Qualifications:
High school graduate or equivalent preferred
Excellent interpersonal, organizational, communication and customer service skills
Ability and willingness to learn multiple tasks and technical requirements of the job
Ability to use technical information to solve problems
Must meet minimum age requirements to perform specific job functions
Must be able to meet the physical requirements of the position, with or without reasonable accommodations
Physical Requirements:
Ability to use computers and other communication systems required to perform job functions
Perform repetitive hand and arm motions
Bend and lift products weighing up to 15 lbs. continuously, 25 lbs. frequently, and 50 lbs. on occasion
Pull or push up to 75 lbs. on occasion
Stand 100% of the time, frequently walking short distances
Be able to handle a variety of substances associated with cleaning and packaging materials, fresh fruits, vegetables, house plants/flowers and household cleaners
Use hands to frequently/continuously handle currency (paper and coin) as well as operate a variety of equipment such as cash register, lottery machine (where applicable), scanner, computer, and calculator
Frequent reaching and grasping at waist level: occasionally above shoulder or below waist level
Meet established volume activity standards for the position
Tolerate working in extreme hot/cold temperatures for up to 20 minutes at a time
Have sufficient visual ability to check ID cards, checks, invoices and other written documents
Food Lion provides equal employment opportunities to all associates and applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related conditions) national origin, age, disability, sexual orientation, veteran status, gender identity or gender expression or any other characteristic protected by law.
If you have a disability and require assistance in the application process, please contact our Recruiting Department at ***********************
QA Document Control Associate
Quality assurance specialist job in Fall River, MA
Job Title: QA Document Control Associate FLSA Classification: Full-Time, Professional Work Hours: General Shift: 08:30 AM - 5:00 PM (May vary based on business needs) Reports To: QA QMS Lead Salary Range: $64,272 - $77,662 PURPOSE
The QA Document Control Associate in a pharmaceutical environment is responsible for managing controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11, ICH, and ISO. This role supports the Quality Management System (QMS) by maintaining accurate, secure, and accessible documentation throughout its lifecycle, including creation, review, approval, distribution, and archival.
JOB DESCRIPTION
The QA Document Control Associate position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The position reports to the QA QMS Lead and may be matrixed to other functional leaders within the Quality. The essential and typically expected job duties for this position include but are not limited to the following:
* Maintain the Documentation Control Room.
* Receive approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents, etc. after proper verification ensuring GDP.
* Issue the approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents, etc. to cross functional department based on requirements.
* Scan the document and keep them with proper naming.
* Arrange all the documents with proper naming and proper tracking within documentation control room.
* Train staff on document control procedures and Good Documentation Practices.
* Maintain the accessories/day to day item required to maintain the documentation control room.
* Support internal and external audits by providing accurate documentation packages.
* Manage controlled documents such as SOPs, batch records, validation protocols, and specifications.
* Send the document to outside agencies after proper scanning.
* Control the issuance, tracking, retrieval, and final reconciliation of all site-critical logbooks for equipment and controlled areas.
* Enforce strict adherence to Data Integrity principles (ALCOA+) and GxP documentation practices during all processing steps.
* Assist in the preparation and execution of internal and external audits by efficiently locating and retrieving requested controlled documentation.
* Involve in department QMS such as deviation, CAPA, Change Control, APQR preparation.
* Any other work assigned by Operation Lead, QMS Lead, Head Unit Quality Assurance and Quality Head.
EDUCATION AND EXPERIENCE QUALIFICATIONS
* Bachelor's degree industrial management or related field of study from an accredited college/university is required for this position.
* Minimum of three (3) years' experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
* Experience in MDI preferred.
KNOWLEDGE, SKILLS, AND ABILITIES
* Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
* Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
* Effective interpersonal relationship skills and the ability to work in a team environment.
* Proficiency in the English language to include usage, spelling, grammar and punctuation.
* Must have current Good Manufacturing Practices (cGMP) knowledge.
* Must have strong attention-to-detail.
* Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
* Must have strong organization and communication skills (written, verbal, and presentation).
* Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.
GLOBAL COMPANY
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.
Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.
CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)
About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.
EEO Statement:
Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.
QA Document Control Associate
Quality assurance specialist job in Fall River, MA
Job Title: QA Document Control Associate
FLSA Classification: Full-Time, Professional
Work Hours: General Shift: 08:30 AM - 5:00 PM (May vary based on business needs)
Reports To: QA QMS Lead
Salary Range: $64,272 - $77,662
PURPOSE
The QA Document Control Associate in a pharmaceutical environment is responsible for managing controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11, ICH, and ISO. This role supports the Quality Management System (QMS) by maintaining accurate, secure, and accessible documentation throughout its lifecycle, including creation, review, approval, distribution, and archival.
JOB DESCRIPTION
The QA Document Control Associate position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The position reports to the QA QMS Lead and may be matrixed to other functional leaders within the Quality. The essential and typically expected job duties for this position include but are not limited to the following:
Maintain the Documentation Control Room.
Receive approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents, etc. after proper verification ensuring GDP.
Issue the approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents, etc. to cross functional department based on requirements.
Scan the document and keep them with proper naming.
Arrange all the documents with proper naming and proper tracking within documentation control room.
Train staff on document control procedures and Good Documentation Practices.
Maintain the accessories/day to day item required to maintain the documentation control room.
Support internal and external audits by providing accurate documentation packages.
Manage controlled documents such as SOPs, batch records, validation protocols, and specifications.
Send the document to outside agencies after proper scanning.
Control the issuance, tracking, retrieval, and final reconciliation of all site-critical logbooks for equipment and controlled areas.
Enforce strict adherence to Data Integrity principles (ALCOA+) and GxP documentation practices during all processing steps.
Assist in the preparation and execution of internal and external audits by efficiently locating and retrieving requested controlled documentation.
Involve in department QMS such as deviation, CAPA, Change Control, APQR preparation.
Any other work assigned by Operation Lead, QMS Lead, Head Unit Quality Assurance and Quality Head.
EDUCATION AND EXPERIENCE QUALIFICATIONS
Bachelor's degree industrial management or related field of study from an accredited college/university is required for this position.
Minimum of three (3) years' experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
Experience in MDI preferred.
KNOWLEDGE, SKILLS, AND ABILITIES
Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
Effective interpersonal relationship skills and the ability to work in a team environment.
Proficiency in the English language to include usage, spelling, grammar and punctuation.
Must have current Good Manufacturing Practices (cGMP) knowledge.
Must have strong attention-to-detail.
Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
Must have strong organization and communication skills (written, verbal, and presentation).
Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.
GLOBAL COMPANY
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.
Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.
CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)
About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.
EEO Statement:
Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.
Quality Assurance Associate
Quality assurance specialist job in Fall River, MA
Reviewing and confirming the compliance related to raw materials, in process and finished product analytical documents. Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure. Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs). Review of laboratory audit trials during data review against standard operating procedures (SOPs). Coordinating with the Analytical Laboratory Teams to arrange required documents to cross functional teams. Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents. Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor of necessary improvements in the identified areas. Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance. Performing other departmental and cross-functional projects and assignments given by the manager/supervisor.
Skills
capa, deviation, batch record review, quality assurance, chemistry, gmp, hplc, quality control, audit
Top Skills Details
capa,deviation,batch record review,quality assurance,chemistry,gmp
Additional Skills & Qualifications
Possess a minimum bachelor's degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master's degree in the above and/or related fields of study as noted above preferred. A minimum of 1-3 years in analytical (preferably in analytical quality assurance). Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs. Knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good Documentation Practices (GDP), etc. General shift but must be willing and able to work any assigned first or second shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs. Must be willing to work some weekends based on business needs as required by management. Relocation negotiable. No remote work available. This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. The role may be assigned on a work-shift basis where required (Day, Evening, Night). Weekend or Holiday work may be requested or required based on business needs.
Experience Level
Entry Level
Job Type & Location
This is a Permanent position based out of Fall River, MA.
Pay and Benefits
The pay range for this position is $62400.00 - $75400.00/yr.
HealthVision 401k Paid HolidayDentail
Workplace Type
This is a fully onsite position in Fall River,MA.
Application Deadline
This position is anticipated to close on Dec 15, 2025.
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.
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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Quality Assurance Associate II
Quality assurance specialist job in Framingham, MA
NYGCI was founded in 2007 in New York State. Since then we have expanded our services footprint to 27+ states within USA, representing our service presence in more than 50% of US.We provide IT Professional Services to local, regional and global customers and reduce their IT risk and maximize their IT performance.
Job Description
The QA Product Release Associate is responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with relevant quality standards, regulations and established procedures. They support the review of batch records, assemble and review batch files, support the completion of the annual product review, maintain and utilize Quality Assurance databases, utilize the SAP System, review documentation for compliance with relevant quality standards, relevant regulatory councils, and other regulatory requirements and perform administrative tasks.. Years of Experience: 3 - 6 Years
Shift Day
Work Schedule: 8:00-5:00
Additional Information
All your information will be kept confidential according to EEO guidelines.
PT Quality Assurance Associate
Quality assurance specialist job in Newton, MA
Job Title: FT/PT Quality Assurance Associate Department: Center Store (Grocery) Reports To: Assistant Store Manager Where Applicable: Evening Manager Primary Purpose: Provide our customers with a clean, safe, inviting place to shop by maintaining standards in accordance with the standard practice manual. Minimize shrink through proper utilization of standard practice.
Duties and Responsibilities:
Maintain an atmosphere of enthusiastic customer awareness with primary emphasis on fast, friendly, and accurate customer service to create a positive shopping experience
Courteous and helpful to other associates
Sweep and clean floors on nights with no scheduled vendor services
Weekly cleaning of Produce, Market and Deli Departments
Clean and organize the store mop room
Find more efficient ways to do the job and seek to reduce costs and improve labor productivity
Follow QA daily check list and sanitation standards set by Food Lion
Follow current Standard Practices regarding cleanup of Hazardous Waste product
Maintain a complete understanding of and adherence to company guidelines, policies and standard practice
Understand and follow Food Safety and Workplace Safety guidelines and procedures
Observe and correct all unsafe conditions that could cause associate or customer accidents
Report all associate and customer accidents in accordance with established Food Lion procedures to the Manager on Duty
Ensure compliance with local, state and federal regulations
Wear the Food Lion uniform complete with name badge, when on duty, has a neat and clean appearance while adhering to the Food Lion dress code
Successfully complete Computer Based Training (CBT), Training Packet and Training Aid courses
Perform all other duties as assigned
Qualifications:
High school graduate or equivalent preferred
Excellent interpersonal, organizational, communication and customer service skills
Ability and willingness to learn multiple tasks and technical requirements of the job
Ability to use technical information to solve problems
Must meet minimum age requirements to perform specific job functions
Must be able to meet the physical requirements of the position, with or without reasonable accommodations
Physical Requirements:
Ability to use computers and other communication systems required to perform job functions
Perform repetitive hand and arm motions
Bend and lift products weighing up to 15 lbs. continuously, 25 lbs. frequently, and 50 lbs. on occasion
Pull or push up to 75 lbs. on occasion
Stand 100% of the time, frequently walking short distances
Be able to handle a variety of substances associated with cleaning and packaging materials, fresh fruits, vegetables, house plants/flowers and household cleaners
Use hands to frequently/continuously handle currency (paper and coin) as well as operate a variety of equipment such as cash register, lottery machine (where applicable), scanner, computer, and calculator
Frequent reaching and grasping at waist level: occasionally above shoulder or below waist level
Meet established volume activity standards for the position
Tolerate working in extreme hot/cold temperatures for up to 20 minutes at a time
Have sufficient visual ability to check ID cards, checks, invoices and other written documents
Quality Assurance Associate II
Quality assurance specialist job in Framingham, MA
NYGCI was founded in 2007 in New York State. Since then we have expanded our services footprint to 27+ states within USA, representing our service presence in more than 50% of US.We provide IT Professional Services to local, regional and global customers and reduce their IT risk and maximize their IT performance.
Job Description
The QA Product Release Associate is responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with relevant quality standards, regulations and established procedures. They support the review of batch records, assemble and review batch files, support the completion of the annual product review, maintain and utilize Quality Assurance databases, utilize the SAP System, review documentation for compliance with relevant quality standards, relevant regulatory councils, and other regulatory requirements and perform administrative tasks.. Years of Experience: 3 - 6 Years
Shift Day
Work Schedule: 8:00-5:00
Additional Information
All your information will be kept confidential according to EEO guidelines.
Quality Assurance Associate
Quality assurance specialist job in Waltham, MA
We are seeking a Quality Assurance Associate to support on-the-floor QA issues within the manufacturing suite. This role requires mitigating gaps and risks for all quality and GMP processes, running investigations for deviations, change controls, CAPAs, and out-of-specifications, as well as reviewing and authoring SOPs.
Responsibilities
* Support on-the-floor QA issues within the manufacturing suite.
* Mitigate gaps and risks for all quality and GMP processes.
* Run investigations for deviations, change controls, CAPAs, and out-of-specifications.
* Review and author SOPs.
Essential Skills Needed
* Quality assurance experience
* Document control
* Batch record review
* CAPA management
* Deviation handling
* Compliance with audits and quality systems management
Qualifications
* BS degree in a specific science with 3-5 years of experience
* Experience supervising or managing direct reports
* Support for GMP requirements and compliance
* Knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH guidelines
Pay and Benefits
The pay range for this position is $25.00 - $27.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* 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 onsite position in Waltham,MA.
Application Deadline
This position is anticipated to close on May 2, 2025.
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 for other accommodation options.