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Quality Assurance Specialist
3737 Market Street Philadelphia, PA 19104 US
Job Description
The Quality Assurance Operations Specialist will: • Performs work under general supervision.
• Provide quality, technical support and oversight during manufacturing activities.
• Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition at Spark.
• Open deviations as appropriate based upon Spark Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition.
• Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed prior to material/lot release.
• Review and evaluate QC testing records and any associated OOS investigations.
• Review, write, revise, and approve SOPs, technical documents, and reports.
• Perform inspection and release of materials used for production and review vendor certificates for completeness / compliance against approved specifications and collaborate with Material Management to release incoming materials for production.
• Compile and maintain metrics for testing results, quality documentation closure, and disposition and evaluate trending data to identify any irregular trends and notify management as required.
• Provide administrative project management support for Quality Management System integration and improvement projects.
• Provide support for Quality Risk Management governance, including maintenance of documentation, risk register, CAPA plans, etc.
• Support coordination of site Change Control Review Board and change control communications with third party license holder.
• Prepare certificate of compliance (CoC) and/or certificate of analysis (CoA) for products for clinical and/or commercial materials.
• Other assigned responsibilities as established by the QA Operations Lead.
Education and Experience Requirements • Bachelors Degree in scientific discipline;
• Minimum of 3-5 years in a regulated manufacturing environment with exposure to Quality and Manufacturing field.
• Knowledge of Quality Systems such as Change Control, Investigations and CAPA;
• Ability to communicate effectively with wide range of personnel;
• Technical writing skills related to investigation reports.
• General working knowledge of relevant governmental regulations, cGMP and guidelines.
Key Skills, Abilities, and Competencies • Works under general supervision
• Strong attention to detail;
• Ability to manage multiple priorities and tasks in a dynamic environment;
• Proficiency with computer programs;
• Ability to work effectively in a team environment
• Ability to establish facts, define problems, collect data and draw valid conclusions;
• Ability to exercise judgment to determine appropriate corrective actions.
• With guidance from senior dept members ability to create and organize cGMP system procedures based on regulatory / compliance regulations.
• Excellent written and verbal skills;
• Ability to work and communicate with contract manufacturers and testing organizations.
Complexity and Problem Solving • Ability to define problems, collect data, establish facts, and draw valid conclusions;
• Analysis and problem-solving skills, including but not limited to the ability to review and analyze manufacturing, quality control and validation data.
• Ability to participate on cross-functional teams in root cause analysis and solution identification.
• Ability to work collaboratively in the process of conflict resolution for resolve deviations, effective CAPAs, and identifying requirements to implement changes in a controlled GMP environment
Internal and External Contacts • Peers and colleagues throughout the organization as well as external, including manufacturing, Quality Control, facilities and vendors.
Pay Rate Range: $30-42/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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