URGENT HIRE Technical Writer
Company: Aerotek
Location: Rockville
Posted on: April 9, 2021
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Job Description:
Description:Individual will ensure deviations/CAPAs/CCs are
timely addressed and closed relating to manufacturing/technical
operations/quality control for the Fill and Finish Facility. Work
closely with department subject matter experts (SMEs) to obtain
pertinent information necessary to write/close deviations,
providing expertise on necessary preventive measures, and to ensure
site deviation metrics are in a controlled state. Individual will
be the SME for defending relevant deviations in GMP audits
(internal and external). Individual will lead and coordinate
efforts for continuous improvement in deviation reduction and
manufacturing operations for the site. - Deviations - investigate
deviations from all departments, perform thorough product impact
analysis, utilize root cause analysis tools and work cross
functionally to implement effective CAPAs. Interview personnel
involved to determine true root cause, work closely with QA to
close deviations prior to deadlines, organize and manage
investigational team meetings. Communicate across multiple groups
and levels to obtain consensus to facilitate deviation closure and
CAPA implementation.- CAPA/CC- Write CAPAs & CCs to meet production
release requirements, support continuous improvement efforts and
operational optimization. Identify appropriate CAPA/CC
implementation plan and/or effectiveness checks.- Additional
Documents - write, review, revise and/or prepare manufacturing
documents (BPRs, RPTs, SOPs, SWIs, etc.) in accordance with cGMPs
and regulatory guidelinesSkills:corrective action plans, quality
assurance, GMP, SOPTop Skills Details:Technical WritingDeviation
WritingQuality InvestigationAdditional Skills &
Qualifications:Bachelor's Degree in Science and/or related
fieldMinimum of 2-5 years of technical writing experience in the
pharmaceutical/biotechnology discipline.Experience Level:Entry
Level About Aerotek:We know that a company's success starts with
its employees. We also know that an individual's success starts
with the right career opportunity. As a Best of Staffing Client and
Talent leader, Aerotek's people-focused approach yields competitive
advantage for our clients and rewarding careers for our contract
employees. Since 1983, Aerotek has grown to become a leader in
recruiting and staffing services. With more than 250 non-franchised
offices, Aerotek's 8,000 internal employees serve more than 300,000
contract employees and 18,000 clients every year. Aerotek is an
Allegis Group company, the global leader in talent solutions. Learn
more at Aerotek.com.The company is an equal opportunity employer
and will consider all applications without regards to race, sex,
age, color, religion, national origin, veteran status, disability,
sexual orientation, gender identity, genetic information or any
characteristic protected by law.
Keywords: Aerotek, Rockville , URGENT HIRE Technical Writer, IT / Software / Systems , Rockville, Maryland
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