Technical Writing Specialist
Spectraforce
Matthews, North Carolina
3 days ago
Job Description
Description:
Technical Writing Specialist
9 months (potential extension)
Holly Springs, NC, 27540
Ideal candidate: B.S. 2-3+ YOE, Strong attention to detail. Microsoft Word programs, GMP and GDP, and Smartsheet experience.
Nice to have: Previous Pharma or biotech experience. Preferably in pharma manufacturing.
Hybrid - 2-3 days onsite per week.
Job Details: Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation. When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality. Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.); Skills: ; MS Office expertise; Smart Sheets expertise, previous technical writing experience; regulated environment experience; document version control experience; excellent communication/writing skills
Day to Day Responsibilities:
• Documentation Creation and Maintenance: Develop, write, and maintain standard operating procedures (SOPs), batch records, validation protocols, and other technical documents.
• Compliance: Ensure all documentation meets GMP standards and regulatory requirements, including FDA, EMA, and other relevant authorities.
• Collaboration: Work closely with cross-functional teams including Quality Assurance, Quality Control, Manufacturing, and Regulatory Affairs to gather necessary information and ensure accuracy in documentation.
• Review and Edit: Review and edit technical documents to ensure clarity, consistency, and completeness.
• Training Materials: Develop training materials (training qualification documents and answer keys) to assist in the onboarding and continuous education of plant personnel.
• Support Audits: Provide documentation support during internal and external audits and inspections.
• Continuous Improvement: Participate in continuous improvement initiatives to enhance documentation processes and systems.
• Go to the manufacturing floor, as required, to learn Mfg. processes when writing SOPs
Basic Qualifications
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
Top 3 Must Have Skill Sets:
Mastery of Microsoft Word program
GMP and GDP
Smartsheet
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
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: $30.00/hr.
Technical Writing Specialist
9 months (potential extension)
Holly Springs, NC, 27540
Ideal candidate: B.S. 2-3+ YOE, Strong attention to detail. Microsoft Word programs, GMP and GDP, and Smartsheet experience.
Nice to have: Previous Pharma or biotech experience. Preferably in pharma manufacturing.
Hybrid - 2-3 days onsite per week.
Job Details: Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation. When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality. Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.); Skills: ; MS Office expertise; Smart Sheets expertise, previous technical writing experience; regulated environment experience; document version control experience; excellent communication/writing skills
Day to Day Responsibilities:
• Documentation Creation and Maintenance: Develop, write, and maintain standard operating procedures (SOPs), batch records, validation protocols, and other technical documents.
• Compliance: Ensure all documentation meets GMP standards and regulatory requirements, including FDA, EMA, and other relevant authorities.
• Collaboration: Work closely with cross-functional teams including Quality Assurance, Quality Control, Manufacturing, and Regulatory Affairs to gather necessary information and ensure accuracy in documentation.
• Review and Edit: Review and edit technical documents to ensure clarity, consistency, and completeness.
• Training Materials: Develop training materials (training qualification documents and answer keys) to assist in the onboarding and continuous education of plant personnel.
• Support Audits: Provide documentation support during internal and external audits and inspections.
• Continuous Improvement: Participate in continuous improvement initiatives to enhance documentation processes and systems.
• Go to the manufacturing floor, as required, to learn Mfg. processes when writing SOPs
Basic Qualifications
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
Top 3 Must Have Skill Sets:
Mastery of Microsoft Word program
GMP and GDP
Smartsheet
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
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: $30.00/hr.