Quality Associate I, OperationsThe Quality Associate I, Operations is responsible for actively participating in "on the floor" Quality activities during product manufacturing and/or packaging. Quality activities include product sampling and inspection, area clearance to confirm process readiness, non-conforming event support to resolve in-process issues. Communicates to multiple departments and supervision to provide timely process and issue updates.
Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement.Essential FunctionsQuality OperationsPerforms physical inspection of in-process and finished product samples as assigned and according to the production schedule.Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirementsBecomes competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging.Follows internal processes related to controlled substancesPerforms GMP-related verifications such as line clearances, cleaning, room inspection, and materials.Collects and appropriately labels packaging retain samples, and submits to the archive storage.May execute computer data entries in CME, JDE, LIMS, and department databasesCollects retain samples and performs sample evaluation for Annual Product ReviewMay backup third party product review/releasePerform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components or release testingNon-Conforming EventsResponds to and escalates events identified during production to Quality ManagementParticipates in investigations with the Rapid Response Team as neededProcess ImprovementCollaborates with Manufacturing and Quality partners to identify and implement improvementsComplianceConducts GMP walkthroughs of facilitiesLearns how to perform in-process audits to identify adherence to SOPs and BPR requirementsActively participates in training events, and maintains currency with assigned training requirementsSafetyFollows all procedures to ensure a safe and compliant work environment.QualificationsEducation & ExperienceHigh school diploma or equivalent with 2-4 years' relevant industry (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)Knowledge & SkillsAbility to communicate and work with teamsAttention to detailStrong documentation skillsAbility to read and interpret SOPs and function within the scope of proceduresProficiency with basic math skills and basic experience with computers and software applications requiredAbility to learn new processes and proceduresAble to communicate effectively with other departments, management and operational personnelCustomer/Stakeholder focused (understands impact of daily work to compliance and overall business)Proof-reading skills; ability to identify errorsAbility to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs)Experience with Enterprise Resource Planning (ERP) system is a bonusAbility to work overtime as needed, including occasional weekend shiftsPhysical RequirementsLift 15 lbs.Walk across plant/warehouseWear appropriate gowning as requiredAbility to read for extended periods of time