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Specialist Quality Assurance

Company: Aerotek
Location: West Greenwich
Posted on: April 9, 2021

Job Description:

Top Skills Details:Previous QA oversight of manufacturing, analytical and engineering activities; experience in investigations and quality systems process knowledge. (beginner to intermediate level of experience)Biotech- quality assurance/manufacturing experience (insight into quality assurance) (beginner to intermediate level)Ability to gather relevant information to understand and solve complex problems and make scientific risk-based decisions. (troubleshooting experience/problem solving/ to best provide a quality assurance concepts)soft skillsDemonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with peers, manufacturing partners, and management staff. This role requires a high level of communication as there are 20 people so the candidate will need to be able to effectively communicate what was done and be able to pick up and ask questions from the previous shift.Description:The Quality Assurance Specialist will be responsible for PQA On the Floor in support of Manufacturing activites. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. Quality Assurance On-the-Floor position Shift 3 (4 days a week Tuesday through Friday 10 hours per day 10pm - 8am provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regard to compliance and quality systems with the adaptability to support alternate shifts as the business need requires.Responsibilities include the following:Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.Ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, Corrective Action/Preventative Actions (CAPA),Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.Establish and enable LEAN practices.Oversee and provide guidance during on-the-floor analytical testing.Ensure that changes that could potentially impact product quality are assessed according to procedures.Ensure that deviations from established procedures are investigated and documented per procedures.Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.Alert management of quality, compliance, supply and safety risks.Complete required assigned training to permit execution of required tasks.Drive operational improvement initiatives, programs and projects.Skills:Quality assurance, Gmp, Batch record review, Capa, Sop, TrackwiseAdditional Skills & Qualifications:Basic QualificationsDoctorate degreeORMasters degree and 1 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experienceORBachelors degree and 2 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experienceORAssociates degree and 5 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experienceORHigh school diploma / GED and 7 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experiencePreferred QualificationsScientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing TechnologiesPrevious QA oversight of manufacturing, analytical and engineering activitiesExperience in investigations, change controls, and CAPAs processes system knowledgeDirect Validation experience with pharmaceutical or biopharmaceutical processesAbility to evaluate compliance issues and interact with regulatory inspectorsExperience and training in EDMQ, Trackwise, Maximo, LIMSExperience in managing multiple, competing priorities in a fast-paced environmentExperience leading and/or managing teamsDirect bulk drug substance and drug product experienceAbility to solve complex problems and make scientific risk-based decisionsExperience representing Amgen while interacting with representatives of regulatory agenciesExperience of trending analysisDemonstrated proficiency using Excel, Word and Power PointSchedule:Quality Assurance On-the-Floor position Shift 3 (4 days a week Tuesday through Friday 10 hours per day 10pm - 8am About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Warwick , Specialist Quality Assurance, Other , West Greenwich, Rhode Island

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