Technical writer jobs in Biddeford, ME

Are you looking for an opportunity with plenty of growth potential? Do you enjoy working in an exciting, fast-paced, collaborative environment? Are you interested in working with the world's most innovative companies to create a more connected world? Connecting Continents. Impacting Communities. The backbone of the Internet is a series of high-tech subsea fiber optic cables deployed throughout the globe - SubCom has deployed over 50% of them. Our employees ensure data communications networks are engineered, manufactured, deployed to the highest standards, enabling faster and more reliable connectivity to communities worldwide. Every member of the SubCom team plays a role in an end-to-end process that is critical to enterprises, governments, big cities, and rural towns. We encourage, expect, and value creativity, thoughtful risk taking, openness to change, and diverse perspectives. Whether you're a seasoned applicant seeking a new and exciting challenge, or you're new to the workforce and looking for a flexible, rewarding, and fast-paced position with an innovative and stable organization (since 1953), SubCom has opportunities to advance your career. Position Overview The End User Documentation (EUD) Technical Writer is responsible for producing and maintaining SubCom's established set of technical equipment user manuals, system operations & maintenance descriptions, and product-specific training manuals. This work is conducted in direct support of existing supply contracts, new bids and proposals, and future hardware and software development. The production of these highly technical documents must satisfy contractually required customer deliverable requirements as well as ensure safe and sustaining use of SubCom provided equipment for our customers. Responsibilities * Gather and review source material from Subject Matter Experts (SMEs) from R&D and other functional groups. * Write, construct, assemble and edit manuals based upon SubCom's established styles, guidelines and processes. * Cross check all information against known sources, submit completed manuals to SMEs for review and sign-off. * Develop potential new EUD for new products via SME interviews, requirements documents, and actual use of said product under laboratory conditions. * Design, edit and manipulate graphics in multiple formats, for inclusion within documents. * Support the development and maintenance of on-line help for SubCom's software products. * Desktop publish completed documents for delivery to SubCom Purchasers. * Work to specific and changeable development and delivery schedules. * Attend weekly team status meetings to report on progress of assignments and share key information with other members of the writing staff.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides te chnical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • Ensure timely and efficient creation/review of Label & Pack documents: standard operating procedures, batch records, technical protocols and reports, etc. • Contribute understanding of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (CGMP), analytical skills, and interpretation of the information to be captured on the document • Ensure a consistent style of presentation of Label and Pack documents to maintain quality and ease of review • Coordinate with Engineering on tasks for validation qualification, preventative maintenance and re-qualification program processes • Act as subject matter expert (SME) for documentation with Development and Training (D&T) , and provide input in cross-functional teams, including during Quality Assurance (QA) and Quality Control (QC). • Help develop OJT's for proficiency of L&P staff with respect to process knowledge and critical parameters; ensure understanding and interpretation of results from tools deployed in the process • Support readiness for regulatory inspections and compliance audits. • Assess current documentations for Error Reduction updates and ensure timely revision and review of periodic review • Support development of junior analysts through mentoring • Coordinate CAPA tasks with document changes for timely closure of compliance events with deviations investigators • Revise standard operating procedures as needed • sPractice safe work habits and adhere to Sanofi's safety procedures and guideline Skills: • Minimum of 5 years of experience in a regulated environment • Previous experience with technical writing for manufacturing in a regulated environment • Use of documentation controls systems to manage workflow Qualifications Education: Bachelor's degree in a related discipline Additional Information For more information, please contact Akriti Gupta ************

Mindlance Inc. is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at ************************* · Job Title: Technical Writer · Request-ID: 5025-1 · Duration: 06+ months · Location: Andover, MA, 01810 Job Description: · Author and revise manufacturing batch records and procedures. Manage document workflows. Collaborate with quality and manufacturing staff to resolve questions and concerns with the documentation. · Please list out the (up to) top 3 critical skills: organization of work attention to detail interface with many people and manage workflows · How many years' experience are required?: 0-2 years · What is the minimum education experience required?: associate degree

+ We are looking for a Technical Writer to make our existing content more complete, organize it in a more friendly way and make implementation and optimization more independently actionable by partners. + The team mission is to be the trusted place where travelers go for the most useful information to make fast, effortless decisions. Our team helps scale the growing Travel ecosystem through high-value services and solutions that empower partners and travelers worldwide. + The contractor will work with program managers, engineers and subject matter experts to gather business requirements and product knowledge, identify gaps and areas for improvement and create required content. **Responsibilities:** + Write, review, publish, and maintain high-quality technical content while adhering to client's documentation standards. + Incorporate feedback from relevant stakeholders (e.g., engineers, product managers, program managers, customers) to align content with user needs and product/program goals + Address primary critical documentation needs as compiled in Documentation Needs Analysis and this component. + Identify and address gaps in help content and assist with content development prioritization. + Expand help content to make it actionable and partners more self-sufficient. + Ensure breadth of features/functionality has been documented with best practices and sample use cases. + Address backlog of outstanding bugs and feature requests filed against the Help Center by internal/external users. **Experience:** + Experience in technical writing, product documentation, or online publishing. + Experience working in collaboration with technical and sales stakeholders on a daily basis. + Must be a self-starter who is able to manage multiple tasks under tight deadlines and work independently. + Ability to quickly grasp and communicate technical concepts. **Desired Skills:** + Experience with travel industry a strong plus. **Education:** + Bachelor's degree or equivalent practical experience. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** (********************************** . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Works directly with system analysts and programmers to write and edit program and system documentation, user manuals, training courses, and procedures. Conducts research about product by interviewing subject matter experts, reviewing existing documentation, and using the application. Authors end-user documentation. Edits documentation projects, including copy, pre-press and accuracy editing. Follows through on documentation project to completion, including client signoff, production and archival. Having 3-6 years experience. Key Requirements: Proven technical writing experience for software products Experience with Microsoft 365 tools (Teams, OneDrive, Power Automate) Hands-on SharePoint authoring/admin experience Ability to simplify complex concepts for non-technical audiences Visual design proficiency (diagrams, screenshots, flowcharts) Responsibilities: Gather information from subject matter experts Create and update user guides, help articles, and training materials (including videos) Manage and organize documentation in SharePoint Implement content management best practices (versioning, taxonomy) Edit and proofread for clarity and consistency Review new features/releases for documentation accuracy

The Technical Writer is responsible for creating, revising, and maintaining clear, accurate, and compliant documentation to support pharmaceutical manufacturing operations. This includes standard operating procedures (SOPs), batch records, training materials, and other compliance documents. The role ensures all documentation meets Good Manufacturing Practices (GMP), FDA, EMA, and internal quality standards, and supports cross-functional teams in achieving operational excellence. Technical Writer will be responsible for authoring, reviewing, and controlling all Good Manufacturing Practice (GMP) documentation related to the transfer and scale-up of client drug products. The primary focus of this role is to translate complex technical process descriptions and engineering data into clear, concise, and compliant Master Batch Records (MBRs) for use in aseptic manufacturing operations. Duties and Responsibilities Document Creation & Maintenance : Write, edit, and maintain SOPs, batch records, and other technical documents for manufacturing and operation, based on Tech Transfer documents and process changes. Ensure the MBRs are written clearly for the end-user (Manufacturing Operators) to minimize errors and deviations. Regulatory Compliance : Ensure all documentation complies with GMP, FDA, EMA, and other relevant regulatory standards, as well as internal policies. Collaboration : Work closely with manufacturing, quality assurance, validation, safety, and engineering teams to gather technical information and ensure accuracy and clarity in documentation. Lead document review process, consolidating and incorporating feedback from Subject Matter Experts (SMEs). Process Improvement : Translate complex technical processes into concise, user-friendly instructions to enhance operational efficiency and reduce errors. Document Control : Manage document lifecycle, including version control, reviews, approvals, and archiving, using electronic document management systems (EDMS). Initiate and execute Change Control requests for all MBR and SOP updates. Training Support : Assist in developing training materials based on SOPs and provide support to ensure effective implementation of procedures. Continuous Improvement : Identify opportunities to improve documentation processes, readability, and usability, incorporating feedback from end-users. Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable Supervisory Responsibilities N/A Experience Two plus (2+) years of technical writing experience, preferably in pharmaceutical or sterile manufacturing environments or a CDMO. Education Bachelor's degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related field. Certification in Technical Writing (e.g., AMWA, STC) or GMP training is a plus Knowledge, Skills & Abilities Exceptional technical writing and editing skills with a focus on clarity, accuracy, and conciseness. Demonstrated understanding of aseptic processing, cleanroom environment controls, terminology and cGMP manufacturing operations. Proficiency in document management systems (e.g., MasterControl) and Microsoft Office Suite. Ability to work collaboratively with cross-functional teams and manage multiple projects under tight deadlines. Knowledge of regulatory guidelines (e.g., 21 CFR Part 211, ICH Q7). Attention to detail, analytical thinking, and strong organizational skills. Exceptional verbal communication skills. Physical Requirements Ability to meet gowning requirements. Ability to remain stationary for prolonged periods. Satisfactory audio-visual acuity.

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description Responsible for developing procedural documents in collaboration with Subject Matter Experts (SMEs) in Global Drug Safety including: - Meet with the SMEs to determine the process and the status of the existing procedure - Develop plan for the revision to the document - Make requested updates to the procedure - Circulate drafts to the SMEs and stakeholders for review. Incorporate changes. Mediate discussions on conflicting requests. - Review procedures for formatting and grammer errors as well as for clarity and accuracy - Assist SME with collecting feedback on draft procedure and collecting documentation of approvals - Potentially draft high level messages useful for training and communication on each procedure Additional Information All your information will be kept confidential according to EEO guidelines.

The mission of the Boston Public Health Commission (BPHC) is to work in partnership with communities to protect and promote the health and well-being of all Boston residents, especially those impacted by racism and systemic inequities. The BPHC envisions a thriving Boston where all residents live healthy, fulfilling lives free of racism, poverty, violence, and other systems of oppression. All residents will have equitable opportunities and resources, leading to optimal health and well-being. The BPHC sets an expectation that all staff and leadership commit, individually and as part of the BPHC team, to hold ourselves accountable to establishing a culture of antiracism and advance racial equity and justice through each of our bureaus, programs, and offices. We are seeking a Public Health Fellow to support an exceptional opportunity to work alongside leadership and to bridge the gap between complex scientific analysis and clear, impactful communication. This position is for a period of six months and is located within the Center for Public Health Science and Innovation. The Fellow will collaborate closely with leadership teams across the Commission to ensure crucial public health information is conveyed with clarity and precision. Reporting to the Director of Epidemiology and Evaluation this role ensures the accurate and accessible dissemination of research findings and technical information to diverse audiences, including stakeholders, academic peers, and the public. By employing expertise in research synthesis, manuscript development, and editorial precision, the position supports the creation of high-quality publications and reports that advance knowledge, inform policy, and contribute to evidence-based decision-making in public health. The ideal candidate will have a demonstrated interest in population health dynamics and social determinants of health. Competitive applicants will have superior writing skills, robust quantitative skills, and an aptitude for translational research in population health and social epidemiology. Essential Functions Draft and submit well-crafted, high-quality manuscripts that meet publication requirements in peer-reviewed journals. Lead and actively participate in the preparation of written reports and oral presentations summarizing data analysis results, including detailed description of statistical methods, detailed analysis of results, and synthesis of conclusions for internal and external meetings, scientific conferences, and academic journals. Conduct critical literature review of epidemiological and surveillance studies for study design and publication efforts. Collaborate with leadership to present study findings clearly and accurately. Ensure adherence to submission guidelines for journals. Support development of content for social media, newsletters, and web pages to communicate study outcomes to improve the visibility of research initiatives with measurable audience engagement across communication channels. Create and support creation of visually engaging materials to simplify complex information for non-technical audiences. Collaborate effectively in a team environment. Keeps abreast of the latest statistical techniques, their implementation and interpretations. Perform other duties as directed by leadership.

Boston Globe Opinion has an opening for an opinion writer. The position's duties will include writing unsigned editorials, longer reported commentary, and shorter signed columns. For this position we are particularly interested in adding to our range of voices a writer who can thoughtfully articulate conservative or right-leaning perspectives. Boston Globe Opinion is a team of about 25 journalists whose mission is to present incisive, clear, and informative commentary on a wide range of topics and from diverse points of view. We believe that an informed readership benefits from journalism that challenges as well as bolsters their beliefs. Responsibilities: In this role, the writer will be expected to participate in thrice-weekly editorial board meetings and to produce a regular cadence of unsigned editorials representing the collective view of the board. We are a regional news organization that focuses mainly on local and even hyperlocal issues. But we also weigh in on pressing national and international debates. In all these things, we strive for clarity, fairness, common sense, and well-reported judgments. The job requires working collegially with other board members who might come to the table with sharply differing points of view. Writing editorials is only part of the job. This writer will also have the freedom to write signed columns about personal and public topics of their choosing, in collaboration with their editor. And they will be encouraged to do longer reported commentary for our Sunday Ideas section. Hitting the street, talking to people, and reading relevant documents and reports will always be stressed over armchair opining. The writer will also be asked to contribute to our other digital products. These include weekly newsletters on politics and other subjects, short posts for Substack and social media, and short-form video. On occasion they might be asked to join in panel discussions on our weekly podcast, Say More. Qualifications: Understanding how to craft thoughtful, compelling, and clear editorials, first-person narratives, and in-depth commentary is vital. But we are also looking for candidates who are skilled in the basics of news reporting. That means comfortably navigating fast-breaking and chaotic events; locating and analyzing documents; conducting in-depth interviews; and writing swiftly. Curiosity, intellectual independence, humility, analytical reasoning, and the creativity to generate compelling ideas are essential qualities for the job. A sense of humor is always a plus. So is the ability to write elegantly and with voice. The ideal candidates should have some experience working for a daily news organization or weekly news magazine. Bonus points for demonstrated skill in hosting and/or producing short-form video, and optimizing written pieces for search and social. Double bonus points to candidates who are familiar with New England generally and the Boston area specifically. Though we are looking for applicants whose world views lean right-of-center, we value open-mindedness and a sense of fairness over ideological purity. The BGMP office is located in downtown Boston, near Faneuil Hall and Quincy Market, and is easily accessible by MBTA and commuter rail lines. This position is based in Boston, and candidates should be based in the area or willing to move. The hourly rate for this role is $41.29 - $53.84. This position is a union position covered by a collective bargaining agreement with the Boston Newspaper Guild. 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. EEO Statement: At Boston Globe Media, our mission is to empower, connect, and convene our communities with independent, trusted journalism and storytelling. We know a critical part of achieving this is by having a workforce that is representative of the communities we serve. Boston Globe Media is an equal opportunity employer that welcomes candidates and colleagues of all backgrounds, experiences, perspectives, and skills.

Through the compassion and commitment of our supporters, staff, partners and volunteers, The Greater Boston Food Bank (GBFB) takes a bold, innovative and multi-pronged approach to achieve our mission to end hunger here. GBFB is the largest hunger-relief organization in New England and among the largest food banks in the country. We are committed to increasing our food distribution to provide three meals a day to every person in need in Eastern Massachusetts while supporting healthy lives and healthy communities. Our progress toward this goal is documented by town on our interactive map. The Greater Boston Food Bank is a member of Feeding America, the nation's largest hunger- relief organization. Through compassion and action, together we can create a hunger free Eastern Massachusetts. GBFB Team Members will support the Mission to End Hunger Here. They will live our Team Member Values of Team Member Wellbeing, Teamwork, Diversity Equity and Inclusion, Respect, Trust and Our Eastern Massachusetts Community. Required: Interested candidates must submit a resume, cover letter, and writing samples that demonstrate persuasive and research-based writing . Position Summary The Part-Time Writer will play a crucial role in advancing GBFB's mission to end hunger in Eastern Massachusetts by producing high-quality, compelling written content. The writer will report to the Director of Communications and collaborate with team members to develop materials that support GBFB's fundraising, communications, marketing, public affairs and public relations efforts. This position requires a talented, research-savvy writer capable of developing persuasive communications that inform, inspire, and engage various audiences, including donors, partners, the media, elected officials, and the broader community. The writer will collaborate with team members to develop materials that support GBFB's fundraising, communications, marketing, public affairs and public relations efforts. Essential Duties and Responsibilities Content Development: Create persuasive content, including donor appeals, impact reports, press releases, newsletters, and blog posts. Adapt tone and style to suit different audiences and communication channels. Research and Storytelling: Conduct independent research to inform content, including gathering data and analyzing trends related to food insecurity and community impact. Interview clients, donors, and stakeholders to develop compelling stories that highlight GBFB's mission and achievements. Collaborative Projects: Partner with internal teams to create marketing materials, annual reports, and event communications. Ensure all content aligns with GBFB's messaging and brand voice. Editing and Proofreading: Review and refine content to ensure clarity, accuracy, and grammatical correctness. Edit existing materials to optimize impact and engagement. Other Responsibilities: Stay informed about GBFB's programs, initiatives, and industry trends to produce timely and relevant content. Attend occasional team meetings or events, as needed, to support writing assignments. Skills and Qualifications Exceptional writing, editing, and storytelling skills. Ability to conduct thorough research and synthesize complex information into clear, engaging narratives. Strong organizational skills and ability to manage multiple deadlines. Proficiency in Microsoft Office and familiarity with content management systems (preferred). Experience in nonprofit writing or similar fields a plus. Knowledge, Skills and Abilities: Proven ability to write persuasively Excellent time and project management skills and ability to meet deadlines. Ability to build relationships with GBFB stakeholders including donors, prospects, colleagues, and others. Strong organization skills and attention to detail. Ability to manage multiple priorities. Ability to work both independently and as a member of a team. Strong professional demeanor, placing a high value on offering excellent customer service. Demonstrates the required digital competencies that result in the effective usage of the full range of digital technologies at GBFB. Strict discretion and sensitivity in maintaining confidentiality. Genuine appreciation of GBFB's mission and the ability to authentically communicate it. The writer must be available for 10-12 hours of work a week, and be a New England based resident Mandatory Education and Experience: Bachelor's degree required. Advanced degree preferred. Excellent interpersonal, presentation, writing, and communications skills. Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel, Outlook.). Strong proficiency with CRM databases and ideally Salesforce. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to deliver successfully in an increasingly competitive marketplace. With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including. Collabera awarded Best Staffing Company to work for in 2012 by SIA. (hyperlink here) Collabera listed in GS 100 - recognized for excellence and maturity Collabera named among the Top 500 Diversity Owned Businesses Collabera listed in GS 100 & ranked among top 10 service providers Collabera was ranked: 32 in the Top 100 Large Businesses in the U.S 18 in Top 500 Diversity Owned Businesses in the U.S 3 in the Top 100 Diversity Owned Businesses in New Jersey 3 in the Top 100 Privately-held Businesses in New Jersey 66th on FinTech 100 35th among top private companies in New Jersey *********************************************** Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance. Job Description Position Details: Industry Telecom Work Location Waltham - MA - 02451 Job Title Technical Writer Duration 6+ months (High possibility of extension) Job Id 78_36470_Technical Writer Skills and Qualifications: • Goal is to convert so please be aware of your candidates right to work status when submitting. • Technical writer with experience writing and delivering documentation for network hardware end users rather than API. API is nice to have but not a requirement. • Experience and knowledge of mobile services/apps and cloud platforms (mobile advertising a plus). • Experience writing technical content for end users and developers, including reference manuals, user guides, and design specifications. • Familiarity with scripting and programming concepts/languages preferred. Work closely with product management, engineering project teams, and other stakeholders to write and deliver customer-focused technical documentation for product releases. • Address content gaps, act on internal and direct customer feedback, and promote continuous improvement on the documentation experience. If you are not interested in the role or if now isn't a great time for a move, just let me know if I can help in the future or if you need assistance in making a connection. To know more about Collabera, please visit us on ***************** Should you have any questions, please feel free to call me on ************. I look forward to working with you. Additional Information If you are interested, you may reach me at: Deeksha Mathur ************ *******************************

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Ensure timely and efficient creation/review of QCRM documents (material specifications, standard operating procedures, test methods, technical protocols and reports, etc.) Contribute scientific knowledge, analytical skills, and interpretation of the information to be captured on the document Ensure a consistent style of presentation of QCRM documents to maintain quality and ease of review Execute activities, associated with optimization, validation, transfer, and life cycle management of test methods used for release testing of raw materials Coordinate and conduct tasks for laboratory equipment calibration, qualification, preventative maintenance and re-qualification program Act as subject matter expert (SME) for method validation, laboratory equipment management and supplier certification testing, and provide input in cross-functional teams, including during Consent Decree remediation activities. Provide training and ensure adequate proficiency of QCRM staff with respect to analytical method principle and critical parameters; ensure understanding and interpretation of test results Support readiness for regulatory inspections and compliance audits. Assess routine compendial updates and ensure timely revision of test methods Review data generated by contract laboratories (internal and external labs) Support development of junior analysts through mentoring Execute and ensure timely closure of compliance events, including deviations, CAPA, change controls Revise standard operating procedures as needed Practice safe work habits and adhere to Genzyme s safety procedures and guidelines Maintain proficiency training per assigned curricula Qualifications Skills: Basic Qualifications: Bachelor s degree in a related discipline Minimum of 5 years of experience in cGMP laboratory environment Previous experience with management of lab equipment Previous experience with lab control operations and quality systems Education: Bachelor s degree in a related discipline Previous experience with lab control operations and quality systems . Additional Information Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter

Duration: 12+ month Top 3 critical skills: · Strong working knowledge of the validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures. · Working knowledge of data integrity regulations, guidance, and principles · Strong technical writing skills Minimum education experience required: BS in Scientific discipline Years of experience required: 3-5 years Job Description: This role will provide support to the QC Analytical and Microbiology departments for QC instrument data integrity assessments and remediation activities. This scope includes QC Instruments (both portable and computer-controlled), paper-based systems, and local instances of enterprise system data management. Systems and processes within scope will require assessment via company's pre-established criteria in order to identify gaps against company data integrity expectations. The candidate will be responsible for executing or facilitating execution of these gap assessments through collaboration with laboratory subject matter experts (SMEs) at company. Upon completion of gap assessments, the candidate will be responsible for leveraging the results as follows: • Facilitating, proposing, and/or assembling gap closure recommendations, through collaboration with SMEs • Summarizing results from their assessments into reports utilizing a supplied format • Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short term/completed remediations • Managing all gap assessment and remediation reports through company review and approval workflows • Performing supporting remediation work in the form of SOP revisions as well as authoring and executing change controls and validation test plans/protocols when required per remediation plans Additional Skills: Successful candidate requires: • Strong working knowledge of the validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures. • Working knowledge of data integrity regulations, guidance, and principles • Working knowledge of CAPA and change control processes • Strong technical writing skills • Strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QC, QA Validation, Instrument Validation, and IS/IT functions. • A detail-oriented approach to deliverables as the main job responsibility is generation, review, and approval of GMP documentation. • A BS degree in science, engineering, computer science, or related technical discipline with minimum 2-3 years pharmaceutical/biopharmaceutical experience in a relevant GMP role (validation, quality control, quality assurance, IS/IT compliance, etc.) Past experience working with QC instrumentation in the biopharmaceutical field is preferred but not required. Qualifications • Strong working knowledge of the validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures. • Working knowledge of data integrity regulations, guidance, and principles • Working knowledge of CAPA and change control processes • Strong technical writing skills •Strong interpersonal, oral and written communication skills as there isa high degree of collaboration required between members of QC, QA Validation, Instrument Validation, and IS/IT functions. •A detail-oriented approach to deliverables as the main job responsibility is generation, review, and approval of GMP documentation. •A BS degree in science, engineering, computer science, or related technical discipline with minimum 2-3 years pharmaceutical/biopharmaceutical experience in a relevant GMP role (validation, quality control, quality assurance, IS/IT compliance, etc.) Past experience working with QC instrumentation in the biopharmaceutical field is preferred but not required. Additional Information All your information will be kept confidential according to EEO guidelines.

The Technical Writer is responsible for creating, revising, and maintaining clear, accurate, and compliant documentation to support pharmaceutical manufacturing operations. This includes standard operating procedures (SOPs), batch records, training materials, and other compliance documents. The role ensures all documentation meets Good Manufacturing Practices (GMP), FDA, EMA, and internal quality standards, and supports cross-functional teams in achieving operational excellence. Technical Writer will be responsible for authoring, reviewing, and controlling all Good Manufacturing Practice (GMP) documentation related to the transfer and scale-up of client drug products. The primary focus of this role is to translate complex technical process descriptions and engineering data into clear, concise, and compliant Master Batch Records (MBRs) for use in aseptic manufacturing operations. Duties and Responsibilities Document Creation & Maintenance: Write, edit, and maintain SOPs, batch records, and other technical documents for manufacturing and operation, based on Tech Transfer documents and process changes. Ensure the MBRs are written clearly for the end-user (Manufacturing Operators) to minimize errors and deviations. Regulatory Compliance: Ensure all documentation complies with GMP, FDA, EMA, and other relevant regulatory standards, as well as internal policies. Collaboration: Work closely with manufacturing, quality assurance, validation, safety, and engineering teams to gather technical information and ensure accuracy and clarity in documentation. Lead document review process, consolidating and incorporating feedback from Subject Matter Experts (SMEs). Process Improvement: Translate complex technical processes into concise, user-friendly instructions to enhance operational efficiency and reduce errors. Document Control: Manage document lifecycle, including version control, reviews, approvals, and archiving, using electronic document management systems (EDMS). Initiate and execute Change Control requests for all MBR and SOP updates. Training Support: Assist in developing training materials based on SOPs and provide support to ensure effective implementation of procedures. Continuous Improvement: Identify opportunities to improve documentation processes, readability, and usability, incorporating feedback from end-users. Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable Supervisory Responsibilities N/A Experience Two plus (2+) years of technical writing experience, preferably in pharmaceutical or sterile manufacturing environments or a CDMO. Education Bachelor's degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related field. Certification in Technical Writing (e.g., AMWA, STC) or GMP training is a plus Knowledge, Skills & Abilities Exceptional technical writing and editing skills with a focus on clarity, accuracy, and conciseness. Demonstrated understanding of aseptic processing, cleanroom environment controls, terminology and cGMP manufacturing operations. Proficiency in document management systems (e.g., MasterControl) and Microsoft Office Suite. Ability to work collaboratively with cross-functional teams and manage multiple projects under tight deadlines. Knowledge of regulatory guidelines (e.g., 21 CFR Part 211, ICH Q7). Attention to detail, analytical thinking, and strong organizational skills. Exceptional verbal communication skills. Physical Requirements Ability to meet gowning requirements. Ability to remain stationary for prolonged periods. Satisfactory audio-visual acuity.

Boston Globe Opinion has an opening for an opinion writer. The position's duties will include writing unsigned editorials, longer reported commentary, and shorter signed columns. For this position we are particularly interested in adding to our range of voices a writer who can thoughtfully articulate conservative or right-leaning perspectives. Boston Globe Opinion is a team of about 25 journalists whose mission is to present incisive, clear, and informative commentary on a wide range of topics and from diverse points of view. We believe that an informed readership benefits from journalism that challenges as well as bolsters their beliefs. Responsibilities: In this role, the writer will be expected to participate in thrice-weekly editorial board meetings and to produce a regular cadence of unsigned editorials representing the collective view of the board. We are a regional news organization that focuses mainly on local and even hyperlocal issues. But we also weigh in on pressing national and international debates. In all these things, we strive for clarity, fairness, common sense, and well-reported judgments. The job requires working collegially with other board members who might come to the table with sharply differing points of view. Writing editorials is only part of the job. This writer will also have the freedom to write signed columns about personal and public topics of their choosing, in collaboration with their editor. And they will be encouraged to do longer reported commentary for our Sunday Ideas section. Hitting the street, talking to people, and reading relevant documents and reports will always be stressed over armchair opining. The writer will also be asked to contribute to our other digital products. These include weekly newsletters on politics and other subjects, short posts for Substack and social media, and short-form video. On occasion they might be asked to join in panel discussions on our weekly podcast, Say More. Qualifications: Understanding how to craft thoughtful, compelling, and clear editorials, first-person narratives, and in-depth commentary is vital. But we are also looking for candidates who are skilled in the basics of news reporting. That means comfortably navigating fast-breaking and chaotic events; locating and analyzing documents; conducting in-depth interviews; and writing swiftly. Curiosity, intellectual independence, humility, analytical reasoning, and the creativity to generate compelling ideas are essential qualities for the job. A sense of humor is always a plus. So is the ability to write elegantly and with voice. The ideal candidates should have some experience working for a daily news organization or weekly news magazine. Bonus points for demonstrated skill in hosting and/or producing short-form video, and optimizing written pieces for search and social. Double bonus points to candidates who are familiar with New England generally and the Boston area specifically. Though we are looking for applicants whose world views lean right-of-center, we value open-mindedness and a sense of fairness over ideological purity. The BGMP office is located in downtown Boston, near Faneuil Hall and Quincy Market, and is easily accessible by MBTA and commuter rail lines. This position is based in Boston, and candidates should be based in the area or willing to move. The hourly rate for this role is $41.29 - $53.84. This position is a union position covered by a collective bargaining agreement with the Boston Newspaper Guild. 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. EEO Statement: At Boston Globe Media, our mission is to empower, connect, and convene our communities with independent, trusted journalism and storytelling. We know a critical part of achieving this is by having a workforce that is representative of the communities we serve. Boston Globe Media is an equal opportunity employer that welcomes candidates and colleagues of all backgrounds, experiences, perspectives, and skills.

Through the compassion and commitment of our supporters, staff, partners and volunteers, The Greater Boston Food Bank (GBFB) takes a bold, innovative and multi-pronged approach to achieve our mission to end hunger here. GBFB is the largest hunger-relief organization in New England and among the largest food banks in the country. We are committed to increasing our food distribution to provide three meals a day to every person in need in Eastern Massachusetts while supporting healthy lives and healthy communities. Our progress toward this goal is documented by town on our interactive map. The Greater Boston Food Bank is a member of Feeding America, the nation's largest hunger- relief organization. Through compassion and action, together we can create a hunger free Eastern Massachusetts. GBFB Team Members will support the Mission to End Hunger Here. They will live our Team Member Values of Team Member Wellbeing, Teamwork, Diversity Equity and Inclusion, Respect, Trust and Our Eastern Massachusetts Community. Required: Interested candidates must submit a resume, cover letter, and writing samples that demonstrate persuasive and research-based writing. Position Summary The Part-Time Writer will play a crucial role in advancing GBFB's mission to end hunger in Eastern Massachusetts by producing high-quality, compelling written content. The writer will report to the Director of Communications and collaborate with team members to develop materials that support GBFB's fundraising, communications, marketing, public affairs and public relations efforts. This position requires a talented, research-savvy writer capable of developing persuasive communications that inform, inspire, and engage various audiences, including donors, partners, the media, elected officials, and the broader community. The writer will collaborate with team members to develop materials that support GBFB's fundraising, communications, marketing, public affairs and public relations efforts. Essential Duties and Responsibilities * Content Development: * Create persuasive content, including donor appeals, impact reports, press releases, newsletters, and blog posts. * Adapt tone and style to suit different audiences and communication channels. * Research and Storytelling: * Conduct independent research to inform content, including gathering data and analyzing trends related to food insecurity and community impact. * Interview clients, donors, and stakeholders to develop compelling stories that highlight GBFB's mission and achievements. * Collaborative Projects: * Partner with internal teams to create marketing materials, annual reports, and event communications. * Ensure all content aligns with GBFB's messaging and brand voice. * Editing and Proofreading: * Review and refine content to ensure clarity, accuracy, and grammatical correctness. * Edit existing materials to optimize impact and engagement. * Other Responsibilities: * Stay informed about GBFB's programs, initiatives, and industry trends to produce timely and relevant content. * Attend occasional team meetings or events, as needed, to support writing assignments. Skills and Qualifications * Exceptional writing, editing, and storytelling skills. * Ability to conduct thorough research and synthesize complex information into clear, engaging narratives. * Strong organizational skills and ability to manage multiple deadlines. * Proficiency in Microsoft Office and familiarity with content management systems (preferred). * Experience in nonprofit writing or similar fields a plus. Knowledge, Skills and Abilities: * Proven ability to write persuasively * Excellent time and project management skills and ability to meet deadlines. * Ability to build relationships with GBFB stakeholders including donors, prospects, colleagues, and others. * Strong organization skills and attention to detail. * Ability to manage multiple priorities. * Ability to work both independently and as a member of a team. * Strong professional demeanor, placing a high value on offering excellent customer service. * Demonstrates the required digital competencies that result in the effective usage of the full range of digital technologies at GBFB. * Strict discretion and sensitivity in maintaining confidentiality. * Genuine appreciation of GBFB's mission and the ability to authentically communicate it. * The writer must be available for 10-12 hours of work a week, and be a New England based resident Mandatory Education and Experience: Bachelor's degree required. Advanced degree preferred. Excellent interpersonal, presentation, writing, and communications skills. Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel, Outlook.). Strong proficiency with CRM databases and ideally Salesforce. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Key Responsibilities: Ensure timely and efficient creation/review of QCRM documents (material specifications, standard operating procedures, test methods, technical protocols and reports, etc.) Contribute scientific knowledge, analytical skills, and interpretation of the information to be captured on the document Ensure a consistent style of presentation of QCRM documents to maintain quality and ease of review Execute activities, associated with optimization, validation, transfer, and life cycle management of test methods used for release testing of raw materials Coordinate and conduct tasks for laboratory equipment calibration, qualification, preventative maintenance and re-qualification program Act as subject matter expert (SME) for method validation, laboratory equipment management and supplier certification testing, and provide input in cross-functional teams, including during Consent Decree remediation activities. Provide training and ensure adequate proficiency of QCRM staff with respect to analytical method principle and critical parameters; ensure understanding and interpretation of test results Support readiness for regulatory inspections and compliance audits. Assess routine compendial updates and ensure timely revision of test methods Review data generated by contract laboratories (internal and external labs) Support development of junior analysts through mentoring Execute and ensure timely closure of compliance events, including deviations, CAPA, change controls Revise standard operating procedures as needed Practice safe work habits and adhere to Genzyme s safety procedures and guidelines Maintain proficiency training per assigned curricula Skills: Bachelor s degree in a related discipline Minimum of 5 years of experience in cGMP laboratory environment Previous experience with management of lab equipment Previous experience with lab control operations and quality systems Qualifications Bachelor s degree in a related discipline Previous experience with lab control operations and quality systems Additional Information Regards, Akriti Gupta Associate Recruiter(Scientific & Clinical Division) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance. Job Description Description: • We are currently looking for a cGMP Technical Writer who will be responsible for writing, reviewing and driving production and quality documentation to approval. • The Technical Document Writer will be responsible for producing high-quality cGMP documentation that contributes to the overall success of our project goals. • Additional responsibilities might include tracking of the daily, weekly and monthly forecasted documentation priorities required to meet output quotas. Key responsibilities/essential functions: • Originate, revise and maintain Standard Operating Procedures (SOPs), Production Batch Records (PBRs) and Solution Preparation Records. • Compile and draft procedural documentation using standard electronic publishing tools. • Create and maintain templates for cGMP documents. • Collaborate with individuals from various internal functional areas to generate and review new equipment, processing, set-up and operational documents within agreed upon timelines. • Interview subject matter experts to obtain details in order to accurately capture content material. • Demonstrate effective written and verbal communication skills. • Monitor the flow of production documents and adjust workload and resources in an appropriate, organized and efficient manner. • Work with cross-functional teams on the implementation of process improvement initiatives to increase quality in cGMP documentation. • Demonstrate an ability to multi-task and manage multiple projects independently • Maintain a safe work environment for self and staff. Quality Specific Goals: • Aware of and comply with the client Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. • Complete all planned Quality & Compliance training within the defined deadlines. • Identify and report any quality or compliance concerns and take immediate corrective action as required. • Aware of and comply with Stop Order, Concessions, ESD ECO, Calibration, Preventative Maintenance, Material Identification & Segregation, and Good Documentation Practices, as associated with this job type/position. Training: Aware of and comply with client training requirements. Qualifications Required Qualifications: • 3+ years of previous technical writing experience in a cGMP pharmaceutical environment. • Experience in manufacturing under cGMP guidelines and possess a strong knowledge of cGMP requirements. • Prior experience working in a biotech/pharmaceutical company. • Exceptional written/verbal communication, listening, organizational, interpersonal, research, investigative, and problem-solving skills. • Proven ability to communicate complex ideas in a clear, concise manner. • Working knowledge of MS Office Suite and an Electronic Document Management System (EDMS). • Experience with Document Proficiency in MS Office Products. Preferred Qualifications: • Associates degree in a scientific discipline or equivalent experience. • Cell Culture experience. • Protein Purification experience. • Biological Technical Transfer experience. Additional Information To know more about this position please contact after applying to the position on; Ujjwal Mane *************************** ************

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides te chnical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • Ensure timely and efficient creation/review of Label & Pack documents: standard operating procedures, batch records, technical protocols and reports, etc. • Contribute understanding of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (CGMP), analytical skills, and interpretation of the information to be captured on the document • Ensure a consistent style of presentation of Label and Pack documents to maintain quality and ease of review • Coordinate with Engineering on tasks for validation qualification, preventative maintenance and re-qualification program processes • Act as subject matter expert (SME) for documentation with Development and Training (D&T) , and provide input in cross-functional teams, including during Quality Assurance (QA) and Quality Control (QC). • Help develop OJT's for proficiency of L&P staff with respect to process knowledge and critical parameters; ensure understanding and interpretation of results from tools deployed in the process • Support readiness for regulatory inspections and compliance audits. • Assess current documentations for Error Reduction updates and ensure timely revision and review of periodic review • Support development of junior analysts through mentoring • Coordinate CAPA tasks with document changes for timely closure of compliance events with deviations investigators • Revise standard operating procedures as needed • sPractice safe work habits and adhere to Sanofi's safety procedures and guideline Skills: • Minimum of 5 years of experience in a regulated environment • Previous experience with technical writing for manufacturing in a regulated environment • Use of documentation controls systems to manage workflow Qualifications Education: Bachelor's degree in a related discipline Additional Information For more information, please contact Akriti Gupta ************