Clinical - QA Associate, Clinical Studies

CSD-JD-QA Associate – Clinical SuppliesThis is an on-site contract opportunity. Three months with potential extension. Under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Follows established protocols and work plans. May be assisted by QA Specialists and Sr. Specialists. Comply with divisional and site Environmental Health and Safety requirements.Essential Functions:Responsible for inspection of incoming materials for GMP productionAssist with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing, label inspection, line clearance, etc.)Reviews production batch records, logbooks and other associated documentsPerforms Quality verification of just-in-time labeling activitiesPerforms document issuance, scanning, filing and archival activitiesRevises SOPs, Work Instructions and Forms pertaining to their area of focus, as neededAssists in the execution of efficiency improvement projects with guidanceEnsures that products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPsParticipates in Quality programs, procedures and controls to ensure that products conform to established standards and agency guidelinesEnsures gathering of data, investigations and deviations are timely and compliantFollows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelinesRespond and interact with internal and external clients in a professional and timely mannerAll other duties as assignedPosition Requirements:Education or Equivalent: Associate's degree or equivalent knowledge and experience.Experience: Six Sigma or ASQ certification preferred.Knowledge/Skills Requirements:Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule formMust be able to use existing procedures to solve routine and non-routine problemsMust be able to utilize all elements of the quality system to identify, classify and control the status of incoming materialsRecognizes unmet needs within department and businessMust anticipate and identify unmet customer needsBe able to proactively address work issues at the individual and team levelMathematical and scientific reasoning abilityAbility to identify aberrant data and potential quality/compliance concerns escalating to managementExcellent written and verbal communications skills with internal and external customers, peers and managersLead by example according to our values and cultureAbility to collaborate with peers and demonstrate leadership capabilities in a matrix environmentStrategy is focused on personal time management and efficiencyWell organized with ability to multitaskAbility to work effectively under pressure to meet deadlinesPhysical Requirements:On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 poundsSpecific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequentlyMay require the use of a respiratorImportant Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to View email address on click.appcast.io.