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Quality - Manager, Quality Assurance Scientist
Manati, Puerto Rico · Biotech/PharmaceuticalThis is a position for a Senior Quality Assurance Scientist, it is position will not be supervising
Position: Manager, Quality Assurance Scientist (will not be supervising)
Hybrid/OnSite: 100% On SIte
PRINCIPAL OBJECTIVE OF POSITION
Accountable for assuring that the manufacturing and/or support areas operations (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others) are performed in compliance with domestic and international cGMP regulations, and Client policies and procedures and for providing scientific approach and Quality assurance direction to the approval of the GMP documents such as batch records, forms, protocols, procedures, qualification, and validation reports. Enforce critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination to guarantee that gaps are properly addressed. Comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
MAJOR DUTIES AND RESPONSIBILITIES:
1. 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 practice.
2. 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.
3. Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.
4. Provides key technical guidance and oversight to manufacturing and/or support areas operations areas (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others to assure the appropriate cGMPs are in place through quarterly, monthly, weekly, or daily operations audits, as applicable.
5. Ensures compliance of all procedures (SOP’s) to avoid potential regulatory and compliance issues; including GDP and electronic systems compliance.
6. 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.
7. Supports actively the investigation processes in manufacturing areas (Sterile and Non Sterile) and support areas such as Warehouse, QC laboratories, IT, MS&T, facilities and utilities providing coaching from Quality perspective.
8. Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities.
9. Supports risk analysis process when required per procedures.
10. Evaluates product impact and provide lot disposition recommendation when an investigation is completed as needed.
11. Manages audit observation, investigations, change control and CAPAs records in applicable QMS on timely manner.
12. Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards.
13. Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings, as required.
14. 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 CR’s, SOP’s, BR’s, Forms, Logbooks, BOM’s, WPP’s, qualification and validation Protocols, according with government regulations and BMS Policies.
15. Provides support to the area QA Leader during the budget preparation activities.
16. Evaluates department performance indicators and develop the appropriate corrective actions if needed
17. Assists management during internal and regulatory agencies inspections (FDA, DEA, MCA, etc).
18. Develops sampling plans based on acceptance quality level criteria when additional or special testing is required.
19. Performs trend analysis to provide recommendations in order to improve the process and /or the
product quality.
20. Supports Media Fill activities in order to assure that typical and atypical interventions are performed as established.
21. Supports the Annual Product Review elements for Quality events of manufacturing and environmental monitoring.
22. Evaluates and approve the instrumentation and equipment calibration records and critical area engineering drawings.
23. Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.
24. 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 (APQR’s) elements.
25. Approves or reject procedures impacting drug products, raw material or packaging components.
26. Verifies compliance with Client Policies and Guidelines.
27. Participates as quality representative or liaison in site projects
28. Performs pre-operational review form approval in the manufacturing and packaging area.
29. Performs shop floor walk through audits and challenge adherence with area procedures, coaching and Quality Support in alignment to the business unit to optimize compliance and efficacy.
30. Verifies consistency with other site procedures and/or specifications.
31. Reviews and approves investigations related to process, products, utilities, microbiology laboratory and calibrations.
32. Approves Corrective and Preventive actions (CAPA’s).
33. Approves or reject specifications impacting drug products, raw material or packaging components.
34. Ensures there are effective systems for the maintenance and calibration of equipment and approves of calibration requests.
35. Ensures the designation and monitoring of storage conditions for quarantine materials and products.
36. Reviews and approves procedures related to process, products, utilities, and laboratories.
37. Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials.
DECISION MAKING:
• Incumbent has to make firm decisions and recommendations regarding implementation of government regulations and corporate policies to achieve full compliance of the operational areas.
• Incumbent has to take actions as deemed necessary and/or to communicate management in a prompt manner. Inappropriate decision or action 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.
• Incumbent has to meet with the necessary areas to assure prompt solution of quality issues.
• The incumbent will be capable to work with minimum supervision.
• On 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 operation procedures and policies.
EDUCATION:
• 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 a pharmaceutical industry.
• 3-5 years of practical experience in Quality Systems (eg, Investigations, CAPA, Change Control) in a GMP manufacturing environment.
KNOWLEDGE / SKILL:
• Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) with six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry, or Doctoral Degree (PhD) in Pharmacy with valid License in Pharmacy (Good Standing and / or without Restrictions of Puerto Rico Board of Pharmacy).
• Knowledge of manufacturing operations of Oral Solid Dosage and Parenteral Products Manufacturing
• Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use
• Fully bilingual (Spanish/English) communication skills, both written and verbal.
• Self-motivated, creative and team work oriented
• Technical and scientific capability to make firm decisions and recommendations
• Excellent interpersonal skills and the ability to interact with people at all levels
• Effective communication Skills
• Sense of urgency and analytical thinking
• Proficient knowledge of computer systems (Microsoft Office etc.) and applications like Trackwise and SAP
• Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results
• Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)
• Willing to work irregular hours, rotative shifts, weekends and holidays when needed
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
Position: Manager, Quality Assurance Scientist (will not be supervising)
Hybrid/OnSite: 100% On SIte
PRINCIPAL OBJECTIVE OF POSITION
Accountable for assuring that the manufacturing and/or support areas operations (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others) are performed in compliance with domestic and international cGMP regulations, and Client policies and procedures and for providing scientific approach and Quality assurance direction to the approval of the GMP documents such as batch records, forms, protocols, procedures, qualification, and validation reports. Enforce critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination to guarantee that gaps are properly addressed. Comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
MAJOR DUTIES AND RESPONSIBILITIES:
1. 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 practice.
2. 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.
3. Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.
4. Provides key technical guidance and oversight to manufacturing and/or support areas operations areas (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others to assure the appropriate cGMPs are in place through quarterly, monthly, weekly, or daily operations audits, as applicable.
5. Ensures compliance of all procedures (SOP’s) to avoid potential regulatory and compliance issues; including GDP and electronic systems compliance.
6. 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.
7. Supports actively the investigation processes in manufacturing areas (Sterile and Non Sterile) and support areas such as Warehouse, QC laboratories, IT, MS&T, facilities and utilities providing coaching from Quality perspective.
8. Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities.
9. Supports risk analysis process when required per procedures.
10. Evaluates product impact and provide lot disposition recommendation when an investigation is completed as needed.
11. Manages audit observation, investigations, change control and CAPAs records in applicable QMS on timely manner.
12. Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards.
13. Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings, as required.
14. 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 CR’s, SOP’s, BR’s, Forms, Logbooks, BOM’s, WPP’s, qualification and validation Protocols, according with government regulations and BMS Policies.
15. Provides support to the area QA Leader during the budget preparation activities.
16. Evaluates department performance indicators and develop the appropriate corrective actions if needed
17. Assists management during internal and regulatory agencies inspections (FDA, DEA, MCA, etc).
18. Develops sampling plans based on acceptance quality level criteria when additional or special testing is required.
19. Performs trend analysis to provide recommendations in order to improve the process and /or the
product quality.
20. Supports Media Fill activities in order to assure that typical and atypical interventions are performed as established.
21. Supports the Annual Product Review elements for Quality events of manufacturing and environmental monitoring.
22. Evaluates and approve the instrumentation and equipment calibration records and critical area engineering drawings.
23. Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.
24. 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 (APQR’s) elements.
25. Approves or reject procedures impacting drug products, raw material or packaging components.
26. Verifies compliance with Client Policies and Guidelines.
27. Participates as quality representative or liaison in site projects
28. Performs pre-operational review form approval in the manufacturing and packaging area.
29. Performs shop floor walk through audits and challenge adherence with area procedures, coaching and Quality Support in alignment to the business unit to optimize compliance and efficacy.
30. Verifies consistency with other site procedures and/or specifications.
31. Reviews and approves investigations related to process, products, utilities, microbiology laboratory and calibrations.
32. Approves Corrective and Preventive actions (CAPA’s).
33. Approves or reject specifications impacting drug products, raw material or packaging components.
34. Ensures there are effective systems for the maintenance and calibration of equipment and approves of calibration requests.
35. Ensures the designation and monitoring of storage conditions for quarantine materials and products.
36. Reviews and approves procedures related to process, products, utilities, and laboratories.
37. Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials.
DECISION MAKING:
• Incumbent has to make firm decisions and recommendations regarding implementation of government regulations and corporate policies to achieve full compliance of the operational areas.
• Incumbent has to take actions as deemed necessary and/or to communicate management in a prompt manner. Inappropriate decision or action 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.
• Incumbent has to meet with the necessary areas to assure prompt solution of quality issues.
• The incumbent will be capable to work with minimum supervision.
• On 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 operation procedures and policies.
EDUCATION:
• 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 a pharmaceutical industry.
• 3-5 years of practical experience in Quality Systems (eg, Investigations, CAPA, Change Control) in a GMP manufacturing environment.
KNOWLEDGE / SKILL:
• Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) with six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry, or Doctoral Degree (PhD) in Pharmacy with valid License in Pharmacy (Good Standing and / or without Restrictions of Puerto Rico Board of Pharmacy).
• Knowledge of manufacturing operations of Oral Solid Dosage and Parenteral Products Manufacturing
• Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use
• Fully bilingual (Spanish/English) communication skills, both written and verbal.
• Self-motivated, creative and team work oriented
• Technical and scientific capability to make firm decisions and recommendations
• Excellent interpersonal skills and the ability to interact with people at all levels
• Effective communication Skills
• Sense of urgency and analytical thinking
• Proficient knowledge of computer systems (Microsoft Office etc.) and applications like Trackwise and SAP
• Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results
• Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)
• Willing to work irregular hours, rotative shifts, weekends and holidays when needed
*Weil Group is proud to be an Equal Employment Opportunity Employer.*