Senior Level Clinical Quality Specialist Jobs

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary

The Senior Quality Assurance Scientist - Shop Floor is responsible for providing Quality Assurance oversight of manufacturing operations to ensure compliance with GMP regulations, internal procedures, and quality standards throughout the production process. This role supports real-time decision-making on the shop floor, offering guidance, risk assessments, and quality direction during product manufacturing while maintaining an independent quality perspective and partnering closely with Operations. Responsibilities also include oversight of support functions such as Warehouse and Quality Control Laboratories, performing QA Batch Record Reviews prior to product disposition, and ensuring all manufacturing activities meet regulatory and quality requirements. For personnel assigned to Inspection/Packaging operations, the role also includes product sampling, inspection, and evaluation activities in accordance with finished product specifications.

Key Responsibilities

• Supports the site inspection readiness state by: (a) conducting routine walkthroughs through operational areas, (b) observing practices versus procedures, (c) interacting with operational personnel, and (d) examining selected batch and non-batch GMP documentation, partnering with Operations to ensure that GMP procedures are consistently followed.
• Takes QA decisions by applying risk assessment and risk management principles to planned and unplanned events/issues during operations, using quality/compliance knowledge, experience and data, and ensuring compliance to GMPs and BMS policies and guidelines.
• Supports deviation resolution by providing timely inputs and coaching to deviation (functional area) owners. Reviews and approves Deviation Reports from the QA standpoint, considering the nature (severity) of the deviation, frequency and how it was detected, as well as compliance elements (e.g., whether the deviation constitutes a departure from a validated state or regulatory filing).
• For personnel assigned to Inspection/Packaging: conducts sampling, inspection and/or evaluation of samples as per finished product specifications and procedures.
• Reviews and approves procedures and other types of GMP documents (e.g., reports, specifications, drawings, Annual Product Quality Review, special protocols), ensuring the documents are aligned to corporate standards and that families of related procedures (e.g., Change Control, Calibrations, Product Inspection) are well connected.
• Supports activities related to maintenance and calibration of equipment.
• Ensures there is appropriate monitoring of storage conditions for quarantine materials and products.
• While reviewing GMP documents, ensures the adequacy and quality of process outputs and that they are feasible and aligned to cGMP/compliance expectations while remaining practical, driving for Right First Time work from self and others.
• Reviews and approves Manufacturing Batch Records (from all steps), supporting the QA Product Disposition process.
• Conducts basic data analysis, as needed, to support deviations, investigations, change management, technical evaluations and other needs.
• Reviews and approves Corrective and Preventive Action (CAPA) deliverables, ensuring they are appropriate to the deviation root cause(s) and the problem statement.
• Provides key inputs and challenges proposed changes (for improvement, related to CAPAs, etc.) in partnership with the proponents, balancing the need to ensure quality/compliance while adopting lean/simplification principles. This may be in support of site projects or other actions managed through the Change Control process and/or procedural change process.
• Provides assistance to operational areas when a new significant GMP practice change is being implemented, coaching personnel on the GMP principles behind the change.
• For Quality-owned deviations, leads the Deviation Assessment and conducts and/or supports investigations as needed. This includes generating Investigation Reports following industry-standard methodologies and technical writing, ensuring the investigation is standalone and of appropriate breadth and depth.
• Actively participates in the deviation investigation process, providing inputs and ensuring a systematic approach using facts, data, technical inputs and quality/compliance considerations. Supports development of Impact Assessments and rationale for further processing.
• Prepares presentations and materials to reinforce training of GMP topics and/or learnings from events.
• Delivers periodic Quality Talks, in partnership with Operations management, to communicate to the Shop Floor the outcome of key initiatives, deviations, investigations, changes, or emerging industry trends.
• Supports site initiatives and projects, in addition to product transfer initiatives and other assignments based on business needs.
• During peaks of qualifications/validations, supports the review and approval of related documentation.
• Supports Media Fills activities, ensuring that typical and atypical interventions are performed as established.
• Supports the Annual Product Review process, for example, with inputs and/or analysis of quality events.
• Supports departmental budget preparation activities, in addition to budget adherence over time.
• Identifies opportunities for continuous improvement and leads/supports them through completion, as needed.
• Manages audit observations, investigations, change control and CAPA records in the applicable Quality Management System (QMS).
• Assists management during internal and regulatory agency inspections.

Responsibility for Action, Decisions and Recommendations

This position acts and makes final decisions on matters related to:
- Batch Records from the QA standpoint.
- Deviation initiation and deviation report approval.
- Standard Operating Procedures (SOPs) and other GMP procedures.
- Continued operation upon detection of unplanned events/deviations while a lot is manufactured or during a GMP process not associated with a specific lot.
- Notification to Management of significant issues and matters.

The person in this role must feel comfortable taking decisions based on cGMPs, compliance and technical inputs from Subject Matter Experts (SMEs), while exercising risk management principles (considering severity, frequency and detection mechanism of issues). The person needs to exercise judgement on the need to escalate, based on facts and data.

Qualifications

• Bachelor’s degree in Science (e.g., Chemistry, Biology, Microbiology, Pharmacy) or Engineering, with six (6) years of experience in a role exercising GMP responsibilities in the pharmaceutical industry.
• 3-5 years of practical experience in Quality Systems (e.g., Investigations, CAPA, Change Control) in a GMP manufacturing environment.
• Knowledge of manufacturing operations of Parenteral Products Manufacturing.
• In-depth knowledge of cGMPs, FDA and EU regulations, and the ability to interpret and apply them for intended use.
• Demonstrable skills in: Problem solving, Critical thinking, Learning capability, Analytical thinking and Attention to detail in review of GMP documents (e.g., Deviation Reports (manual/electronic), SOPs, CAPAs, Logbooks, Reports, Batch Records)
• Ability to identify which matters must be dealt with a sense of urgency; ability to work under fast-paced conditions and to quickly identify when Subject Matter Experts and/or Senior Management must be involved.
• Self-starter with interpersonal skills and the ability to interact with people at all levels.
• Fully bilingual (Spanish/English) with excellent written and verbal communication skills.
• Proficient knowledge of computer systems (Microsoft Office, etc.) and applications such as Trackwise/Infinity and SAP.
• Applies only to current personnel and candidates for positions assigned to the Inspection and Packaging areas: must pass the sight screening test established within the Quality Assurance or Packaging Standard Operating Procedure (SOP).

Shift: Able to work irregular hours, rotational shifts (8-12 hrs) weekends and holidays.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.