Position Title : Quality - Technical writer Duration : 12 Months Work Location : Warren , NJ Work Schedule : Mon -Fri Normal Business Hours
Purpose: The Technical Writing Specialist supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with facility, utility, and equipment qualification. With minimum supervision and given general instructions, this individual independently carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
Required Competencies: Knowledge, Skills & Abilities: • Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality. • Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures. • Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry. • Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities. • Experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports. • Experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls. • Ability to interact effectively with cross-functional groups. • Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously. • Strong written and verbal communication skills, including solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. • Strong computer skills in Microsoft Office Suite – Word, Excel, Outlook and Teams, and the ability to learn new software as required. Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.
Duties and Responsibilities: • Author and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilities. • Author protocol deviations, investigate out of specification results, perform corrective and preventive actions, and execute change controls. • Develop written procedures for operation, cleaning, and maintenance of equipment and systems. • Create all documents in compliance with the client standards and policies. • Provide excellent customer service and support. Maintain a positive relationship with all team members and site customers while promoting a positive team environment.
Education and Experience: a. BA/BS degree required, BS or more advanced degree in science/engineering preferred b. Minimum 5 years of experience in technical writing, with 3 years of technical writing experience in the pharmaceutical industry
Lab w/ blood & animal
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $45.00/hr.