Location: Manati, PR

Responsibilities:

• Interfaces directly with manufacturing and/or support areas operations to ensure that appropriate procedures are in place, through the execution of thorough reviews of procedures against the practice.
• Leads and participates in the critical review of all documents associated with the manufacturing and/or support areas operations, release, packaging, and relevant activities in the operations areas.
• Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation is investigated and resolved by thoroughly reviewing timely corrective actions.
• Provides key technical guidance and oversight to manufacturing and/or support areas operations areas Sterile, NonSterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MST, IM, among others to assure the appropriate cGMPs are in place through quarterly, monthly, weekly, or daily operations audits, as applicable.
• Ensures compliance of all procedures SOPs to avoid potential regulatory and compliance issues including GDP and electronic systems compliance.
• Provides scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified in order to perform a systematic approach.
• Supports actively the investigation processes in manufacturing areas Sterile and Non Sterile and support areas such as Warehouse, QC laboratories, IT, MST, facilities, and utilities providing coaching from a Quality perspective.
• Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities.
• Supports risk analysis process when required per procedures.
• Evaluates product impact and provide lot disposition recommendations when an investigation is completed as needed.
• Manages audit observation, investigations, change control, and CAPAs records in applicable QMS in a timely manner.
• Provides technical guidance and quality assurance support in the transfer of new products and processes to maintain quality standards.
• Participates in Manufacturing Alignment Teams MAT and Project Alignment Teams PAT, department staff, planning, and change control board meetings, as required.
• Evaluates documentation compliance, including data GDP compliance and electronic system data compliance, and its overall management requirements for all manufacturing and support areas, including QC laboratories, such as CRs, SOPs, BRs, Forms, Logbooks, BOMs, WPPs, qualification, and validation Protocols, according to with government regulations and Policies.
• Provides support to the area QA Leader during the budget preparation activities.
• Evaluates department performance indicators and develop the appropriate corrective actions if needed
• Assists management during internal and regulatory agencies inspections FDA, DEA, MCA, etc.
• Develops sampling plans based on acceptance quality level criteria when additional or special testing is required.
• Performs trend analysis to provide recommendations in order to improve the process and or the product quality.
• Supports Media Fill activities in order to assure that typical and atypical interventions are performed as established.
• Supports the Annual Product Review elements for Quality events of manufacturing and environmental monitoring.
• Evaluates and approve the instrumentation and equipment calibration records and critical area engineering drawings.
• Reviews and approves equipment, utilities, and facilities qualification and system life cycle documentation.
• Reviews and approves all process, product, and computer systems validation protocols and reports, change control documentation, redressing reprocessing rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review APQRs elements.
• Approves or rejects procedures impacting drug products, raw material, or packaging components.
• Verifies compliance with Policies and Guidelines.
• Participates as a quality representative or liaison in site projects
• Performs pre-operational review form approval in the manufacturing and packaging area.
• Performs shop floor walk-through audits and challenges adherence with area procedures, coaching, and Quality Support in alignment to the business unit to optimize compliance and efficacy.
• Verifies consistency with other site procedures and/or specifications.
• Reviews and approves investigations related to process, products, utilities, microbiology laboratory, and calibrations.
• Approves Corrective and Preventive actions CAPAs.
• Approves or rejects specifications impacting drug products, raw material, or packaging components.
• Ensures there are effective systems for the maintenance and calibration of equipment and approves of calibration requests.
• Ensures the designation and monitoring of storage conditions for quarantine materials and products.
• Reviews and approves procedures related to processes, products, utilities, and laboratories.
• Maintains management informed via frequent written reports of any problem that might affect the quality and/or timely release of materials Decision Making.
• Describe the position's responsibility for taking action, making final decisions, and developing recommendations.
• Limiting factors might include existing policies, procedures, laws, regulations, internal controls, etc.
• Incumbent has to make firm decisions and recommendations regarding the implementation of government regulations and corporate policies to achieve full compliance of the operational areas.
• The incumbent has to take actions as deemed necessary and/or to communicate with management in a prompt manner.
• Inappropriate decisions or actions regarding a situation may result in a business and quality impact. Sense of urgency and analytical thinking are critical competencies required for this position. Undue delays in tasks execution may result in business and quality impact.
• The incumbent has to meet with the necessary areas to assure prompt solutions to quality issues.
• Describe the nature of supervision received, the degree to which procedures, methods, and goals are outlined by the supervisor, and the immediacy of supervision: The incumbent will be capable to work with minimum supervision. In emergency situations, the incumbent may be required to make immediate decisions on the course of action of a lot without direct consultation.
• Notify immediate supervisor of any inconsistencies or violations to Company operating procedures and policies.
• Contacts Describe the most important working relationships of this position. Include the frequency, level, and the purpose of contacts necessary for effective performance: The incumbent will have interaction with personnel at all levels.
• Daily contact with Planning Department, QC Laboratories, Warehouse, Technical Services, Validation, Information Management, Packaging and Manufacturing departments of the site. Management and Corporate Quality Unit is required.
• Could interact with governmental regulatory agencies, such as FDA, DEA, MCA, etc.

Requirements

• Bachelor's Degree in Science Biology, Chemistry, Engineering, or related EHS field.
• Six (6) years of experience in a role exercising GMP responsibilities in a pharmaceutical industry.
• Three to five (3-5) years of practical experience in Quality Systems (e.g., Investigations, CAPA, Change Control) in a GMP manufacturing environment.
• Fully cognizant of applicable Federal and Commonwealth rules and regulations
• Demonstrated leadership skills
• Demonstrated strong problem-solving, critical thinking, analytical, and learning capabilities, essential for navigating complex processes and ensuring compliance in a regulated environment.
• Maintained high attention to detail in the review of GMP documentation, including deviation reports (manual/electronic), SOPs, CAPAs, logbooks, batch records, and technical reports to ensure accuracy and regulatory compliance.
• Ability to identify what matters require to be dealt with sense of urgency; being able to work under fast-paced conditions and able to quickly identify when Subject Matter Experts and/or Senior Management must be involved.
• Excellent verbal and written communication skills, ability to work under pressure of time, and capable of working with minimal direct supervision.
• Good interpersonal skills and ability to interact with people at all levels.
• Proficient knowledge of computer systems (Microsoft Office, etc.) and applications like Trackwise/Infinity and SAP.
• Fully bilingual (Spanish/English) with excellent communication skills, both written and verbal.
• Availability to work all shifts, overtime, weekends, and holidays. 

Note:

• This position will require the employee to work with chemical, radiological or biological agents that may be hazardous to health if mishandled (including agents who made potentially affect reproduction or the fetus or nursing infants). Employees will be required to follow all safety procedures and use personal protective clothing/equipment where specified.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 39.38/hr.