Spec, Report Writer Associate
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POST DATE 8/27/2016
END DATE 10/13/2016
JOB DESCRIPTIONMilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
SCOPE OF RESPONSIBILITY:
Prepare routine reports (GMP, GLP and non-GLP) for laboratories within the Biologics Department. This position does not have supervisory responsibility for other Report Writers.
PURPOSE OF THE POSITION
THE REPORT WRITER I WRITES REPORTS FROM LABORATORY DATA USING TEMPLATES AND CUSTOMIZED TEXT AS APPROPRIATE.PRODUCE REPORTS THAT MEET RELEVANT QUALITY REGULATORY STANDARDS AND PRACTICES, SUCH AS GLP/ GMP.
ESSENTIAL JOB FUNCTIONS
* Review lab data/ workbooks and accurately represent the data in the final report.
* Identify and/or resolve issues with study raw data/ information appropriately with relevant staff.
* Monitor department s performance in the reporting process including tracking deadlines On Time Delivery (OTD) and Document Error Rate (DER) metrics.
* Coordinate and plan work within technical team to meet and improve deadlines.
* Obtain required signatures and transfer study reports to the appropriate personnel.
* Communicate daily with other departments to resolve outstanding issues
* Assist in the preparation of SOPs and investigation reports relevant to area of report writing responsibility.
* As appropriate generate, control and track revisions to study documentation including statements of work, protocols, protocol and report amendments, lab records, protocol and report templates.
* Track status of laboratory testing and update Excel study tracking files, data trending as appropriate.
* Other tasks and responsibilities as appropriate or required.
* Bachelor s Degree (or equivalent), preferably in a scientific discipline.
* Previous experience in an FDA regulated environment preferred.
* Previous technical writing experience preferred.
Knowledge and Skills:
* Basic knowledge of GLP/GMPs as applicable to assigned tasks.
* Ability to write routine reports with proper grammar, a professional appearance and language which accurately reflects what occurred and flows so that it is easily read and understood.
* Intermediate technical knowledge and ability to analyze data of some scientific complexity.
* Basic knowledge of applicable computer systems (i.e. Excel, Word, PowerPoint, LIMS, BRIQS, etc.)
* Ability to perform and understand scientific calculations.
* Effective communication both written and verbal.
ADDITIONAL LOCAL NEEDS
* No travel required
Approximate Percentage of Time Required
Using fingers, hands, arms to handle, move, manipulate, and reach objects and materials.
Climb or balance
Reach with hands and arms.
Stoop, kneel, crouch or crawl.
Close Vision (Clear vision to work with fine objects at 20 feet or less)
Color Vision (To identify and distinguish colors)
Distance Vision (Clear vision at 20 feet or more)
Depth perception (three-dimensional vision, ability to judge distances and spatial relationships)
Peripheral vision (ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point)
Adjust focus (ability to adjust the eye to bring an object into sharp focus)
Lift weight or exert force up to 50 lbs
Work where air contamination may be present (e.g. dust, fumes, smoke, toxic conditions, disagreeable odors). Describe specific: wear a respirator
Work in improperly illuminated, awkward or cramped work space. Describe specific: Biological safety cabinets.
Work in a wide range of temperatures
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.