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Kelly Services QC Associate - Technical Writer in Mattapan, Massachusetts

JOB TITLE: QC Associate - Technical Writing

Contract-to-Permanent

Kelly Scientific Resources is searching for a QC Technical Writer to work with one of our best clients in Mattapan, MA. The client is the only non-profit, FDA-licensed manufacturer of vaccines in the United States. For over 100 years, they have worked to improve public health through applied research, development and production of biologic products, including vaccines, plasma derivatives and most recently, monoclonal antibodies.

JOB SUMMARY/OBJECTIVE:

Responsible for processing documents for the Quality Control organization. Compiles data for documentation of test procedures and prepares reports. Provides documentation input and support throughout the Quality Control organization (e.g. projects, product transfers and inspections). Ensures procedures, policies and documentation meet and cGMP regulatory standards. Strives to meet objectives on time and is able to multi-task and change priorities as needs arise to support dynamic timelines.

ESSENTIAL JOB FUNCTIONS:

Percentage of Time Spent

Job Function (In order of %)

1)

50%

Support multiple groups within QC and works closely with appropriate Manufacturing personnel to ensure timely completion and readiness of associated documentation.

2)

20%

Actively participates in revisions, providing input, as necessary. Authoring/revising, method development, and validation protocols/reports.

3)

10%

Frequent use & general knowledge of industry practices, techniques and standards. General application of concepts and principles. Assist with developing solutions to variety of problems of moderate scope & complexity. Refers to policies & practices for guidance.

4)

10%

Complete projects assigned by determined deadlines. Able to multi-task efficiently to ensure timely project completion. Assist management in evaluating and implementing new techniques and technologies with guidance.

5)

5%

Improve and develop systems to meet current GMP standards. Document work clearly, accurately, and in accordance with cGMP. Assist with investigations for deviations.

6)

5%

Miscellaneous tasks as necessary.

POSITION REQUIREMENTS:

  • Document work clearly, accurately, and in accordance with cGMP and internal policies/procedures.

  • Has good understanding and application of principles, concepts, practices, and standards inb Quality Control.

  • Recommends and guides implementation of functional strategies across group.

  • Flexible to meet changing demands to support manufacturing activities.

  • Completes tasks where judgment is required in resolving problems & making recommendations.

  • Plan own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities.

EDUCATION AND QUALIFICATIONS:

  • BS in Biological Science or related technical field.

  • At least 3-5 years of related experience or equivalent combination of education & experience.

  • Knowledge of QC testing principles and procedures, as applicable to focus of position.

  • Exposure to cGMP environment.

  • Some knowledge of testing and associated equipment protocols and requirements and applicable instrumentation and procedures.

  • Strong interpersonal and communications skills; written and oral.

  • Understanding of applicable regulatory requirements.

  • Laboratory documentation review and revision experience.

PHYSICAL DEMANDS/FACTORS:

While performing the duties of this job, the employee:

  • Demonstrate excellent organization and time management skills.

  • Ability to work within environmental clean rooms or laboratory setting

  • Ability to function in a dynamic environment and balance multiple priorities simultaneously

  • While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

  • Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.

If this is something you're interested in, please send your most up-to-date resume to edmund.fisher@kellyscientific.com along with your availability for a brief call to discuss the position and your background in more detail.

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—

providing you with opportunities to work on today’s most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a better place. Let Kelly fuel your career—connect with us today.

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 kellyservices.com 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 is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.

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