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Quality - Manager, Quality Assurance Scientist
Manati, Puerto Rico · Biotech/PharmaceuticalThis is a position for a Senior Quality Assurance Scientist, this position will not be supervising
Position: Manager, Quality Assurance Scientist (will not be supervising)
Hybrid/OnSite: 100% On SIte
PRINCIPAL OBJECTIVE OF POSITION
Oversee operations occurring at the Shop Floor Level from the Quality Assurance standpoint, providing direction/guidance/ inputs for GMP decisions, while lots are manufactured. This includes oversight to processes which are not linked directly to a lot (e.g., Warehouse, Quality Control Laboratories). The role entails frequent risk-based judgements, decision making, forming partnerships with operations, while remaining independent.
Personnel in this role also conducts QA Batch Record Review prior to submitting to the Product Disposition group.
For personnel assigned to Inspection/ Packaging, this role conducts direct work related to sampling and evaluation of samples as per finished product specifications.
MAJOR DUTIES AND RESPONSIBILITIES:
1. Supports the site inspection readiness state by: (a) conducting routine walkthroughs through operational areas, (b) observing practices vs procedures, (c) interacting with operational personnel, (d) examining selected batch and non-batch GMP documentation, partnering with Operations to ensure that GMP procedures are consistently followed.
2. Takes QA decisions by applying risk assessment/risk management principles to planned and unplanned events/ issues during operations, using quality/ compliance knowledge and experience, using data, ensuring compliance to GMPs, Client policies and guidelines.
3. Supports deviation resolution by providing timely inputs and coaching to deviation (functional area) owners. In addition, reviews and approves Deviation Reports from QA standpoint, considering the nature (i.e., severity) of the deviation, frequency and how it was detected, as well as compliance elements (e.g., if the deviation constitutes a departure from a validated state or regulatory filing).
4. For personnel assigned to Inspection/ Packaging: conduct sampling, inspection, and/or evaluation of samples as per finished product specifications & procedures.
5. Reviews and approves procedures or other types of GMP documents (e.g., reports, specifications, Annual Product Quality Review, special protocols). The review must ensure that the documents are aligned to corporate standards, that families of procedures (of a related topic) are well connected (e.g., for Change Control, Product Inspection).
6. Ensures there is appropriate monitoring of storage conditions for quarantine materials and products.
7. While reviewing GMP documents, ensures the adequacy and quality of outputs from processes, ensures they are feasible and aligned to cGMP/compliance expectations while being practical, driving for <Right First-Time work> from his/herself and others.
8. Reviews and approves Manufacturing Batch Records (from all steps), supporting QA Product Disposition process.
9. Conducts basic data analysis, as needed to support deviation/investigations/change management/ technical evaluations, and/or other needs.
10. Reviews and approves Corrective and Preventive actions (CAPA’s) deliverables, ensuring they are appropriately to the deviation root cause(s) and deviation (i.e., the problem statement).
11. 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 that are managed through the Change Control process and/or procedural change process.
12. Provides assistance to operational areas when a new significant (GMP practice) change is being implemented, helping coach personnel on the GMP principles behind the change.
13. For Quality-owned deviations, leads the Deviation Assessment and conducts and/or support investigations, as needed. This includes generating Investigation Reports, following industry-standard methodologies, Technical Writing, ensuring the investigation is standalone, having an appropriate breadth & depth.
14. Actively participates in the deviation investigation process, providing inputs, ensuring there is a systematic approach, using facts, data, technical inputs, quality/compliance considerations. Supports development of Impact Assessments and rationale for further processing.
15. Prepares presentations/ materials to reinforce training of GMP topics and/or learnings from events.
16. Delivers periodic Quality Talks, in partnership with Operations management, to communicate to Shop Floor what has been the outcome of key initiatives, deviations, investigations, changes, or emerging industry trends.
17. Supports site initiatives/projects, in addition to the product transfer initiatives and other assignments based on business needs.
18. During peaks of qualifications/ validations, supports the review and approval of related documentation.
19. Support Media Fills activities, ensuring that typical and atypical interventions are performed as established.
20. Supports the Annual Product Review process, for example, with inputs and/or analysis of quality events.
21. Supports departmental budget preparation activities, in addition to budget adherence through time.
22. Identifies opportunities for continuous improvements and leads/ support through completion, as needed.
23. Manages audit observations, investigations, change control and CAPAs records in applicable QMS system.
24. Assists management during internal and regulatory agencies inspections.
DECISION MAKING:
This position acts and makes final decisions on matters related to:
• Batch Records from 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 if manufactured or a GMP process not associated to a specific lot.
• Notification to Management of significant issues/ matters.
The person in this role must feel comfortable taking decisions based on cGMPs, compliance, technical inputs from Subject Matter Experts (SME), while exercising risk management principles (considering severity, frequency and detection mechanism of issues). The person needs to exercise judgement considering needs to escalate, based on facts & data).
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:
1. 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.
2. Three-five years of practical experience in Quality Systems (e.g., Investigations, CAPA, Change Control) in a GMP manufacturing environment.
3. Knowledge of manufacturing operations of Parenteral Products Manufacturing.
4. In depth knowledge of cGMPs, FDA, EU regulations and the ability to interpret and apply them for intended use.
5. Demonstrable Skills needed:
a. Problem Solving;
b. Critical Thinking;
c. Learning Capability;
d. Analytical Thinking;
e. Attention to Details in review of GMP documents (e.g., in Deviation Reports (manual/ electronic), SOPs, CAPAs, Logbooks, Reports, Batch Records).
6. Individual must be able 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.
7. Individual should be a self-starter, with interpersonal skills and ability to interact with people at all levels.
8. Fully bilingual (Spanish/English) with excellent communication skills, both written and verbal.
9. Proficient knowledge of computer systems (Microsoft Office, etc.) and applications like Trackwise/Infinity and SAP.
10. The following pre-requirement only applies to current personnel, and candidates applying, to a position assigned in the Inspection and Packaging areas:
a. Approve the sight screening test established within the Quality Assurance or Packaging Standard Operating Procedure (SOP).
*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
Oversee operations occurring at the Shop Floor Level from the Quality Assurance standpoint, providing direction/guidance/ inputs for GMP decisions, while lots are manufactured. This includes oversight to processes which are not linked directly to a lot (e.g., Warehouse, Quality Control Laboratories). The role entails frequent risk-based judgements, decision making, forming partnerships with operations, while remaining independent.
Personnel in this role also conducts QA Batch Record Review prior to submitting to the Product Disposition group.
For personnel assigned to Inspection/ Packaging, this role conducts direct work related to sampling and evaluation of samples as per finished product specifications.
MAJOR DUTIES AND RESPONSIBILITIES:
1. Supports the site inspection readiness state by: (a) conducting routine walkthroughs through operational areas, (b) observing practices vs procedures, (c) interacting with operational personnel, (d) examining selected batch and non-batch GMP documentation, partnering with Operations to ensure that GMP procedures are consistently followed.
2. Takes QA decisions by applying risk assessment/risk management principles to planned and unplanned events/ issues during operations, using quality/ compliance knowledge and experience, using data, ensuring compliance to GMPs, Client policies and guidelines.
3. Supports deviation resolution by providing timely inputs and coaching to deviation (functional area) owners. In addition, reviews and approves Deviation Reports from QA standpoint, considering the nature (i.e., severity) of the deviation, frequency and how it was detected, as well as compliance elements (e.g., if the deviation constitutes a departure from a validated state or regulatory filing).
4. For personnel assigned to Inspection/ Packaging: conduct sampling, inspection, and/or evaluation of samples as per finished product specifications & procedures.
5. Reviews and approves procedures or other types of GMP documents (e.g., reports, specifications, Annual Product Quality Review, special protocols). The review must ensure that the documents are aligned to corporate standards, that families of procedures (of a related topic) are well connected (e.g., for Change Control, Product Inspection).
6. Ensures there is appropriate monitoring of storage conditions for quarantine materials and products.
7. While reviewing GMP documents, ensures the adequacy and quality of outputs from processes, ensures they are feasible and aligned to cGMP/compliance expectations while being practical, driving for <Right First-Time work> from his/herself and others.
8. Reviews and approves Manufacturing Batch Records (from all steps), supporting QA Product Disposition process.
9. Conducts basic data analysis, as needed to support deviation/investigations/change management/ technical evaluations, and/or other needs.
10. Reviews and approves Corrective and Preventive actions (CAPA’s) deliverables, ensuring they are appropriately to the deviation root cause(s) and deviation (i.e., the problem statement).
11. 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 that are managed through the Change Control process and/or procedural change process.
12. Provides assistance to operational areas when a new significant (GMP practice) change is being implemented, helping coach personnel on the GMP principles behind the change.
13. For Quality-owned deviations, leads the Deviation Assessment and conducts and/or support investigations, as needed. This includes generating Investigation Reports, following industry-standard methodologies, Technical Writing, ensuring the investigation is standalone, having an appropriate breadth & depth.
14. Actively participates in the deviation investigation process, providing inputs, ensuring there is a systematic approach, using facts, data, technical inputs, quality/compliance considerations. Supports development of Impact Assessments and rationale for further processing.
15. Prepares presentations/ materials to reinforce training of GMP topics and/or learnings from events.
16. Delivers periodic Quality Talks, in partnership with Operations management, to communicate to Shop Floor what has been the outcome of key initiatives, deviations, investigations, changes, or emerging industry trends.
17. Supports site initiatives/projects, in addition to the product transfer initiatives and other assignments based on business needs.
18. During peaks of qualifications/ validations, supports the review and approval of related documentation.
19. Support Media Fills activities, ensuring that typical and atypical interventions are performed as established.
20. Supports the Annual Product Review process, for example, with inputs and/or analysis of quality events.
21. Supports departmental budget preparation activities, in addition to budget adherence through time.
22. Identifies opportunities for continuous improvements and leads/ support through completion, as needed.
23. Manages audit observations, investigations, change control and CAPAs records in applicable QMS system.
24. Assists management during internal and regulatory agencies inspections.
DECISION MAKING:
This position acts and makes final decisions on matters related to:
• Batch Records from 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 if manufactured or a GMP process not associated to a specific lot.
• Notification to Management of significant issues/ matters.
The person in this role must feel comfortable taking decisions based on cGMPs, compliance, technical inputs from Subject Matter Experts (SME), while exercising risk management principles (considering severity, frequency and detection mechanism of issues). The person needs to exercise judgement considering needs to escalate, based on facts & data).
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:
1. 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.
2. Three-five years of practical experience in Quality Systems (e.g., Investigations, CAPA, Change Control) in a GMP manufacturing environment.
3. Knowledge of manufacturing operations of Parenteral Products Manufacturing.
4. In depth knowledge of cGMPs, FDA, EU regulations and the ability to interpret and apply them for intended use.
5. Demonstrable Skills needed:
a. Problem Solving;
b. Critical Thinking;
c. Learning Capability;
d. Analytical Thinking;
e. Attention to Details in review of GMP documents (e.g., in Deviation Reports (manual/ electronic), SOPs, CAPAs, Logbooks, Reports, Batch Records).
6. Individual must be able 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.
7. Individual should be a self-starter, with interpersonal skills and ability to interact with people at all levels.
8. Fully bilingual (Spanish/English) with excellent communication skills, both written and verbal.
9. Proficient knowledge of computer systems (Microsoft Office, etc.) and applications like Trackwise/Infinity and SAP.
10. The following pre-requirement only applies to current personnel, and candidates applying, to a position assigned in the Inspection and Packaging areas:
a. Approve the sight screening test established within the Quality Assurance or Packaging Standard Operating Procedure (SOP).
*Weil Group is proud to be an Equal Employment Opportunity Employer.*