Senior QA/QC Associate

AstraZeneca-posted 9 days ago
Full-time • Mid Level
Canóvanas, PR
5,001-10,000 employees
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This position is responsible for all QA activities that directly support execution of the process, both within the PET and in assigned areas outside the PET, ensuring compliance. These activities may include, but are not limited to, Quality on-line review, batch release, change control and documentation, equipment and process validation, investigations, SOPs, supplier management and regulatory interactions. In addition, in the QC area, must perform testing of raw materials, finished products, stability, and other samples received according to business needs and following approved procedures, cGMP’s, cGLP’s, corporate policies, and any other applicable regulatory requirements. At the Senior Level will be trained and demonstrate some level of proficiency in all of the major responsibilities of the role. The incumbent must demonstrate a strong understanding of the area to which the individual is aligned. The incumbent will act as execution lead/process owner for one or more processes. This position will be able to provide assistance to either QA or QC areas. The support will be given on one specific area only and is not allowed to be executed in both areas at the same time.

  • Escalate to QA management (i.e., QA Manager/QC Manager or Head of Quality) any discrepancies (potential or real) during daily operations.
  • Provide expert advice on Good Manufacturing Practice / Good Development Practice / Good Laboratory Practice to Operations and ensure compliance with the associated quality standards.
  • Support major and critical site investigations. Conduct QA / QC area investigations.
  • Support local complaint investigations, identify and rectify any trends.
  • Collate the required documentation for product quality reviews within the required timescales.
  • Apply the first level of risk management by using analytical skills and experience to make decisions, develop solutions, or more complicated judgments, within general operating guidelines.
  • Look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring an appropriate level of compliance.
  • Produce and deliver Good Manufacturing Practice training within the Manufacturing Teams.
  • Identify QA / QC enhancement opportunities, and actively participate and coordinate with QA / QC Management the required activities to implement these opportunities.
  • Ensure plant readiness for any regulatory inspections including periodic walkthroughs.
  • Execute and/or support local audits (both internal and external) to aid in developing follow-up improvement plans to ensure ongoing compliance.
  • Review and approve documentation generated as a result of experimentation, validation, new product technology introduction (i.e., Experimental Programs and Reports, Process and Cleaning Validation, Release Requirements Determination, Computer Validation Lifecycle documents, Risk Assessment for Qualification purposes, Installation Qualification, Operation Qualification, Technical Projects, Applications Change Controls).
  • Support development and implementation of systems or CAPAs identified during audits, regulatory inspection, and pre or post-approval negotiation.
  • Participate in the development and implementation of Quality Risk Assessments (QRA).
  • Participate in project teams created towards problem solving or specific issues, to ensure GMP and regulatory compliance.
  • Train and mentor junior members of the Quality organization and providing QA / QC coaching to other non-QA / QC employees within the area supported.
  • Generates or revises associated documentation including procedures, analytical methods, and other documents with additional technical complexity such as but not limited to special study reports, technical reports or analytical method validation protocols.
  • Builds productive and effective relationship with internal and external customers, such as Manufacturing, Quality Assurance, Planning, and other Laboratory areas to ensure customer satisfaction and business success.
  • Proactively participates in company initiatives toward continuous improvement (New Products Introduction, GMP Improvement Programs, Kaizen events, GENBA walks) while providing guidance in the area knowledge and deliver timely results while contributing to business success.
  • Actively identifies, develops, establishes, monitors and maintains area Key Performance Indicators as required. Take any action needed to prevent situations that may jeopardize the patient safety, quality of the product or supply to market.
  • Perform product release activities and recommend batch disposition.
  • Ensure compliance with change management processes within the Process Execution Team (PET) and approval of associated documentation at a local level.
  • Conducts testing following applicable procedures, cGMP’s, corporate and any other applicable regulation.
  • Ensure is trained and qualified on the corresponding procedures before starting any test or doing any laboratory operation related task.
  • Certifies analytical reports generated in the laboratory ensuring compliance with cGMP’s and applicable specifications, procedures, among others, if applicable.
  • Evaluates data trends and actively participates in the investigation of OOS and atypical events and/or quality issues placing particular attention to root cause analysis, technical completion and scope while ensuring accuracy of documentation contents.
  • Actively support the implementation of compendial changes for raw materials, analytical methods or finished products tests in accordance with applicable Pharmacopoeias such as USP/NF, European Pharmacopoeia, British, and Japanese Pharmacopoeia.
  • Performs instrumentation troubleshooting and preventative maintenance as deemed required to maintain the operational status of instrumentation.
  • Assists in ensuring the laboratory operations are fully an integral part of the LEAN culture and that visual boards are continuously updated representing the current operation.
  • Provide guidance to laboratory activities including the review of quality documentation, such as, product specifications, chemical methods, chemical (analytical) report forms, SOPs, and quality and compliance guidelines.
  • Bachelor’s degree in a Sciences / Technical field such as Pharmacy, Biology, Chemistry or Engineering and at least three (3) years related experience in the pharmaceutical industry with emphasis in Quality or Compliance position; or equivalent combination of education and experience.
  • Fully Bilingual (English & Spanish)
  • Advance knowledge of Microsoft Office applications (i.e., Word, Excel, Project, Power Point, Outlook) or similar computer applications.
  • Advance knowledge of databases/application systems (i.e., SAP, Global LIMS, Documentum, Saba, EQV, Change Controls, Complaints).
  • Adaptable to changing environment.
  • Up to date knowledge of cGMP regulations and end-to-end supply chain management principles. Knowledge of pharmaceutical operations processes: warehouse, manufacturing, packaging, laboratory, in process, etc.
  • Strong ability and motivation to learn.
  • Capable of making timely decisions with facts on hand, even when under pressure.
  • Good communication across all levels or the organization and capable of building and maintaining open lines of communication.
  • Strategic and tactical customer stakeholder management.
  • Understanding of statistical data and capable of drawing or reaching conclusions from supporting data concepts (i.e. normal distribution, percentages, ratios and proportions to practical situations).
  • Ability to read, analyze and interpret common scientific and technical journals, financial reports and technical documents.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Monitors own work to ensure quality. Meets productivity standards. Completes work in timely manner.
  • Demonstrates accuracy and thoroughness.
  • Looks for ways to improve and promote quality. Applies feedback to improve performance.
  • Willing to make decisions. Exhibits sound and accurate judgment.
  • Knowledge in ANSI/ASQ Z1.4 Standard and auditing of documents for GMP compliance.
  • Business Knowledge focused on ensuring continuity of supply, cost-savings and reducing non-value adding activities.
  • Balances team and individual responsibilities. Exhibits objectivity and openness to others' views. Gives and welcomes feedback. Supports everyone's efforts to succeed.
  • Ability to solve practical problems and deal with variables in situations where only limited standardization exists.
  • Health, Pharmacy, Dental and Vision Insurances, STD and LTD Insurances, Retirement Plan with company match and Profit Sharing
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