Senior Associate, Research Operations - Validation
This individual will be a member of the local quality team that supports preclinical and clinical genetic therapy research functions.
This individual will be responsible for driving the equipment and method implementation process including IQ/OQ/PQ, hardware/software, and method validations.
The candidate will have a strong scientific and technical background, a clear understanding of the individual requirements for equipment induction and method validation, and the experience to manage these activities.
The candidate will work closely with IT and CSV staff, as well as scientific staff.
Primary Responsibilities Include Managing equipment induction activities including selection, procurement, qualification, and CSV In collaboration with equipment requestors and IT-Lab Systems, ensuring completion of compliant and accurate induction documentation (e.
g.
, RBA, URS, Config/Design Specs, IQ/OQ/ PQ, user SOP) Reviewing and approving vendor-supplied qualification documentation Reviewing internal validation test scripts, plans, and reports Reviewing and providing input on method validation protocols to ensure scientific rigor Ensuring timely closure of required change controls to align with business needs and corporate procedures Acting as asset owner in BMRAM, approve new induction requests, change controls, and work orders Managing equipment decommissioning activities Maintaining current and accurate inventories of all equipment and software versions, including qualification status Maintaining the integrity of data, both paper and electronic, generated during equipment induction and maintenance Performing all activities in compliance with GLP regulations and corporate SOPs Desired Education and Skills B.
S.
degree in Biology, Molecular Biology, Chemistry, or related field Minimum of 2 years of experience in managing equipment commissioning, including CSV Experience in assay method validations Minimum of 5 years of experience in a quality role, preferably in a GLP environment Experience in immunology, molecular genetics, histology, and/or nonclinical studies is preferred Project management skills preferred Ability to manage multiple projects at one time Ability to work with minimal supervision Excellent planning and problem-solving skills Excellent writing and communication skills Ability to work cross-functionally with people at all levels of the organization Ability to multi-task and adapt quickly to a changing environment LI-TD1LI-OnsiteThis position requires work on site at one of Sarepta's facilities in the United States.
The targeted salary range for this position is $76,000 - $95,000 per year.
Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.
The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.
S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Recommended Skills Biology Business Requirements Change Control Clinical Works Communication Histology Estimated Salary: $20 to $28 per hour based on qualifications.
This individual will be responsible for driving the equipment and method implementation process including IQ/OQ/PQ, hardware/software, and method validations.
The candidate will have a strong scientific and technical background, a clear understanding of the individual requirements for equipment induction and method validation, and the experience to manage these activities.
The candidate will work closely with IT and CSV staff, as well as scientific staff.
Primary Responsibilities Include Managing equipment induction activities including selection, procurement, qualification, and CSV In collaboration with equipment requestors and IT-Lab Systems, ensuring completion of compliant and accurate induction documentation (e.
g.
, RBA, URS, Config/Design Specs, IQ/OQ/ PQ, user SOP) Reviewing and approving vendor-supplied qualification documentation Reviewing internal validation test scripts, plans, and reports Reviewing and providing input on method validation protocols to ensure scientific rigor Ensuring timely closure of required change controls to align with business needs and corporate procedures Acting as asset owner in BMRAM, approve new induction requests, change controls, and work orders Managing equipment decommissioning activities Maintaining current and accurate inventories of all equipment and software versions, including qualification status Maintaining the integrity of data, both paper and electronic, generated during equipment induction and maintenance Performing all activities in compliance with GLP regulations and corporate SOPs Desired Education and Skills B.
S.
degree in Biology, Molecular Biology, Chemistry, or related field Minimum of 2 years of experience in managing equipment commissioning, including CSV Experience in assay method validations Minimum of 5 years of experience in a quality role, preferably in a GLP environment Experience in immunology, molecular genetics, histology, and/or nonclinical studies is preferred Project management skills preferred Ability to manage multiple projects at one time Ability to work with minimal supervision Excellent planning and problem-solving skills Excellent writing and communication skills Ability to work cross-functionally with people at all levels of the organization Ability to multi-task and adapt quickly to a changing environment LI-TD1LI-OnsiteThis position requires work on site at one of Sarepta's facilities in the United States.
The targeted salary range for this position is $76,000 - $95,000 per year.
Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.
The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.
S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Recommended Skills Biology Business Requirements Change Control Clinical Works Communication Histology Estimated Salary: $20 to $28 per hour based on qualifications.
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