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Sr. QA Associate, Validation

Sr. QA Associate, Validation
Overview
Alnylamwas founded in 2002 on a revolutionary vision and bold mission which remainfirmly in place today. We are leading the translation of RNAi as a new class ofmedicines with a core focus on RNAi therapeutics toward genetically definedtargets for the treatment of serious, life-threatening diseases with limitedtreatment options for patients and their caregivers. In January 2015, weannounced our "Alnylam 2020" guidance that reflects our expected transitionfrom a late-stage clinical development company to a multi-productcommercial-stage company with a sustainable development pipeline. Alnylam isproud to have been recognized as one of The Boston Globe's Top Places to Workin 2015, 2016, 2017 and 2018.
Alnylam is seeking an experienced Sr. QA Associate, Validation inthe Supply Chain QA function primarily supporting operations at Alnylam'sNorton, MA manufacturing facility. This position will be responsible for reviewand approval of Validation life-cycle documentation for facility, equipment,utilities (FEU), laboratory equipment qualification (LEQ), as well as processperformance qualification (PPQ), and cleaning validation in support of Alnylaminternal Drug Substance manufacturing capabilities. The individual will also providesupport to the facilities group and internal manufacturing QA operations stafffor the review and approval of PM and Calibration Plans, risk assessments, changecontrols, deviations and CAPAs.
Summary of Key Responsibilities
Reviewand Approval of Validation life-cycle documentation including Master Plans, process design documents, technologytransfers, protocols, reports and process control strategy (PCS) to support qualificationof facilities, equipment, utilities (FEU) and QC laboratory equipment
Performsand makes decisions consistent with cGMPs and Alnylam's quality governance
QAreview and approval of deviations, change controls, CAPAs and EngineeringChange Controls
QAreview and approval of Preventive Maintenance (PM) and Calibration Plans
PerformsGMP release for new FEU, LEQ and GMP areas
Createand Maintain Validation Program metrics
Partneringwith the Validation Engineering group to maintain the company Validation Program
Participatingin cross-functional risk assessments
Additionalduties as assigned.
Qualifications
Minimum,a BS degree in life sciences, engineering or related field
Minimumof 7 years operational quality or validation experience in a GMP manufacturingand supply chain environment
Experiencein the pharmaceutical industry with a strong analytical and quality background
Excellentworking knowledge of Quality Systems, GMP-related requirements and ICHguidelines
Demonstratedteamwork, initiative, and problem-solving skills
Demonstratedproject management skills
Abilityto prioritize and work independently with minimal supervision
Abilityto accurately determine deadlines and ask for help if needed
Detailoriented with solid problem solving acumen
Abilityto work effectively in a team environment with great organization skills
Abilityto independently analyze and reconcile moderate to complex issues
Musthave demonstrated initiative and accountability in a fast paced environment
Excellentverbal and written communication and interpersonal skills
Proficientwith computers and word processing software (i.e., Microsoft Office products)
Alnylam Pharmaceuticals is an EEO employer committed to anexciting, diverse, and enriching work environment.


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