Job SummaryThe Quality Assurance (QA) Specialist II, QA Production Support is a position on the Second Shift. The candidate must demonstrate thorough understanding, knowledge, and ability in primary discipline. The QA Specialist II, QA Production Support is responsible for performing incoming sampling of materials, support room /line clearances and provide QA input into production event resolution to assure that quality operations are in conformance to GMP requirements. Also responsible for identifying compliance deficiencies, providing QA SME input into investigations as required and assisting with the resolution plan.Primary ResponsibilitiesPerform sampling, and inspection on incoming commercial and experimental/clinical raw materials, components, and intermediates.Perform raw material component review to ensure correct quantities, labeling and visual appearance.Oversee the administration of prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.Comprehend and adhere to all related SOPs, company policies, cGxPs, and regulatory requirements.Comprehend and adhere to all pertinent Health and Safety regulations, policies and procedures and the required use of all approved and issued Personal Protective Equipment.Execute activities/tasks (i.e., sampling, cleaning, packaging component testing.) in accordance with approved SOPs, schedules and communicates expected processing times for incoming raw materials, components, and intermediates to appropriate Warehousing, Planning, Operations, Pharm Tech, and Quality management. Efficient and proactive in executing assigned activities.Maintain current training status and close all training gaps in a timely fashion.Prepare and maintain tracking/testing systems, (i.e., LIMS, SAP, Logbooks, OCR, etc.) which are used for testing and to reflect status of samples. Reports status to appropriate laboratory, manufacturing and planning groups at pre-determined intervals.Provide timely day-to-day decisions on compliance related issues in Production, Warehouse/Distribution, Facilities, Incoming QA, Quality Control and Stability areas based on expertise and collection of independently gathered information.Assess accuracy and compliance of plant SOP’s as a SOP reviewer and approver and works with SOP author for timely approvals.Communicate daily with supervision and others within work group as related to specific job function and demonstrate the ability to communicate with others outside of work group.Demonstrate a level of consciousness to safety and health related activities as evident by the daily application of requirements specific to job function; Recognize safety and health related issues and report to supervision.Support and maintain an environment that fosters communication and teamwork within Quality Assurance and related departments.Perform other related assignments and duties as required and assigned.Education and ExperienceBS required with 2 years minimum relevant experience, or equivalent level of experience in pharmaceutical or related industries or graduate degree (MS Preferred) with on-year minimum experience.Necessary Knowledge, Skills, and AbilitiesBasic understanding of applicable regulatory requirements as it relates to job function demonstrated by adherence to policies and procedures;Basic ability to perform computer transactions related to job functions demonstrated by right first-time measures;Ability to perform job function using appropriate instrumentation and applicable techniques demonstrated by efficient and accurate completion of work;Ability to apply technical knowledge and experience in performing job functions as is displayed through independence in daily performance of work;Ability to apply and evaluate systems and procedures for improvement opportunities demonstrated through discussion of recommendations with supervision;Ability to overcomes obstacles to achieve results as indicated by ability to resolve issues and meet timelines;Demonstrate application of industry best practices and specific regulatory requirements for evaluation of systems and procedures for improvement opportunities and communicates results and ideas to supervision on a regular basis;Ability to troubleshoots and recommend improved methods or techniques of performing job function or utilizing instrumentation demonstrated by ability to achieve results, gain right first-time output, and improve efficiency;Ability to utilize multiple IT systems required for job performance and utilize reports for analysis demonstrated by consistent right first-time results and independent resolution of issues.Documentation CompetenciesComplete required documentation accurately according to procedure;Identify potential concerns in data that is reported and communicates concerns to supervision;Perform peer review of data with consistency and accuracy, and assists in resolution of documentation errors;Identify unusual occurrences or data that is aberrant as compared to acceptance criteria or routine analysis and communicates results to supervision;Document and evaluate technical data for indications of negative trends and reports trends to management;Summarize and evaluate data for reporting and analysis and reports results to management;Independently resolve documentation errors with other appropriate departments achieving acceptable corrective action;Act as reviewer of data generated in work group with consistency and accuracy, and assists in resolution of documentation errors.Problem Solving CompetenciesRecommend solutions to issues related to the job function in a timely manner;Troubleshoot and provide immediate solutions for issues related to job function;Execute corrective actions to prevent reoccurring problems.Communication/Team CompetenciesDemonstrate ability to communicate with others outside of work group as related to the specific job function;Contribute to functional areas outside of work group contributing expertise as related to the specific job function;Safety AwarenessEvaluate work related activities to eliminate potential safety or health related issues and implements corrective action. Supervisory Responsibilities (if Applicable)There are no direct reports for this role.Physical and Environmental RequirementsPerform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax or other specialized equipment used in an office setting;Walk, climb and work on step ladders, stairs, and/or platforms while performing line/ room clearances and defect resolution/investigations;Take samples which may require stretching, bending, or twisting to remove product from the equipment/containers (i.e. IQA raw material sampling and label/ outsert/ bottle/closure sampling/testing). Moving drums/bags of raw materials and label rolls/boxes which range in weight from 10-50 lbs;Perform inspections on cleaned and disassemble production equipment which may require pulling, pushing, twisting, and crawling/crouching to remove equipment shields and panels and ensure equipment is clear of foreign product;When necessary, wear appropriate Personal Protective Equipment including PAPR (Powered Air Purifying Respirator), safety glasses, protective gloves, and safety shoes;Ability to work a 10.5 hours per day/4-day work week, Monday-Thursday with overtime as required.Additional InformationThis position is a Quality Specialist II level position. Minimum required education, experience, knowledge, skills and abilities are included in the posting. The position will be filled at the level commensurate with the successful candidate's education, experience, knowledge, skills, and abilities.The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.