Technical Writing Specialist

Spectraforce

Matthews, North Carolina


20 days ago

Similar Jobs
Technical Writing Specialist
Spectraforce
Matthews, North Carolina

20 days ago

Job Description

Job Title: Technical Writing Specialist
Location: Holly Springs, NC
Duration: 03 months
 
Description:
 
Hybrid: up to 60% onsite.
  • Ideal candidate would be someone that can work independently, has a minimum of 8-10 years of experience and strong working knowledge of GMP/regulatory requirements within the QC laboratory. Candidate must have experience writing the following technical documents within the QC laboratory: SOPs/ Equipment Operation and Maintenance Procedures/ Validation and Qualification protocols with little guidance.Create strong technically sound Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures, Equipment Data Integrity Assessments, etc. required to support QC Laboratory Startup· Process document changes within the electronic Quality Management System (eQMS) while ensuring good documentation practices (GDP)
  • Manage document lifecycle updates to support QC Laboratory Readiness metric reporting
  • Author Analytical Equipment Qualification Protocols (Performance Qualification Protocols) and Compendial Verifications
  • Previous experience with the Pharmaceutical Industry, with a strong focus in GMP Quality Control 
Min 8 years' experience performing analytical testing.
Preferred Qualifications * Master degree in Analytical Chemistry, Physical or Pharmaceutical or Life Sciences or Engineering related discipline.
* Strong theoretical understanding, research in, and hands-on experience in small molecule/peptide analysis in support of process development/scale up activities and formulation development in GMP and non-GMP environments
* Experience with a broad array of chromatographic and spectroscopic techniques.
* Demonstrate independence and ability to produce quality results under minimal direction
* Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook
* High energy individual who can multi-task and handle a fast-pace, dynamic work environment
* Operate specialized laboratory equipment and instrumentation
* Complete training on assigned tasks
* Comply with safety guidelines and site specific procedures which include but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books
 
Top 3 Must Have Skill Sets:
Ideal candidate would be someone that can work independently, has a minimum of 8-10 years of experience and strong working knowledge of GMP/regulatory requirements within the QC laboratory. Candidate must have experience writing the following technical documents within the QC laboratory: SOPs/ Equipment Operation and Maintenance Procedures/ Validation and Qualification protocols with little guidance.
  

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. 
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: $37.38/hr.

Similar Jobs