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Technical Document Writer â?? Biomanufacturing, Marlborough, MA

Kelly Services

Marlborough, MA
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Technical Document Writer â?? Biomanufacturing, Marlborough, MA

Jobid US41ALJF_BH1436389

Location: Marlborough, MA, 01752, USA

Description **Technical Document Writer – Biomanufacturing, Marlborough, MA**

**12 Month Contract via Kelly Services**

**Monday – Friday: 8:00am – 4:30pm**

**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.

+ 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 GEHC 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 GEHC training requirements.
**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 Microsoft Office Products.
**Preferred Qualifications:**

+ Associates degree in a scientific discipline or equivalent experience.
+ Cell Culture experience.
+ Protein Purification experience.
+ Biological Technical Transfer experience.
**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

**Why Kelly?**

+ As a Kelly Services employee, you will have access to numerous perks, including:
+ Exposure to a variety of career opportunities as a result of our expansive network of client companies
+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career
+ Access to more than 3,000 online training courses through our Kelly Learning Center
+ Weekly pay and service bonus plans
+ Group-rate insurance options available immediately upon hire*
**Apply Today!**

**Why Kelly** **®** **?**

Kelly puts you in charge of your career, with access to cutting edge projects and technologies inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional interests.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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