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Process Analyst
Manati, PR · Biotech/PharmaceuticalRESPONSIBILITIES
Accountable for timeliness statistical analysis and trending of product batch data to ensure process control and capability and; for product robustness analyses through the overseeing, coordination support, collection and monitoring of product batch information for new and existing products. Incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
1. Leads all product batch records efforts to collect and monitor information for new and existing products.
2. Prepares statistical trending of product batch record data.
3. Analyzes specific process control and capability data and maintains accurate data in the department tracking tools and databases.
4. Evaluates and implements scientific methods for improving the product processing operation.
5. Prepares reports, presentations and reviews data to monitor product processing activities.
6. Leads and participates in out-of-trend product investigations with Senior Product Scientists and represents processing area as requested in fact finding meetings.
7. Leads process robustness initiatives to optimize process control, productivity, and product quality and communicates findings to other functional areas.
8. Updates, reviews, and approves area procedures to assure correct content and compliance with Good Manufacturing Practices.
9. Initiates and leads project change proposals driven pertaining to drug product manufacturing, as required.
10. Participates in the identification of product processing issues and performs investigations to correct and prevent re-occurrence.
11. Manages and resolves operational and technical issues through effective communication and/or escalation within technical, operations and other support departments.
12. Performs other duties as assigned to support processing operations from a technical standpoint.
MINIMUM REQUIREMENTS
• BS in Engineering, Sciences, Information Systems or Statistics-related field
• At least one (1) year experience analyzing data in an pharmaceutical, lyophilization or parenteral manufacturing environments
• Ability to analyze data and detect trends and inconsistencies and to interpret trending situations based on data
• Knowledge in pharmaceutical, lyophilization or parenteral manufacturing processes
• Knowledge of FDA regulatory requirements and relevant governmental regulations, cGMPs, pharmaceutical business processes
• Ability to review SOPs and work instructions, guidelines pertaining to a pharmaceutical manufacturing plant
• Ability to write technical reports pertaining data analyses and trending data and ability to effectively present them
• Ability to interact effectively with people to establish and maintain excellent working relationship with at all organizational levels
• Ability to plan and prioritize multiple complex activities simultaneously and make decisions while balancing speed, quality and risk
• Capability to challenge the status quo to simplify work
• Bilingual English/Spanish, both written and verbal
• Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*
Accountable for timeliness statistical analysis and trending of product batch data to ensure process control and capability and; for product robustness analyses through the overseeing, coordination support, collection and monitoring of product batch information for new and existing products. Incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
1. Leads all product batch records efforts to collect and monitor information for new and existing products.
2. Prepares statistical trending of product batch record data.
3. Analyzes specific process control and capability data and maintains accurate data in the department tracking tools and databases.
4. Evaluates and implements scientific methods for improving the product processing operation.
5. Prepares reports, presentations and reviews data to monitor product processing activities.
6. Leads and participates in out-of-trend product investigations with Senior Product Scientists and represents processing area as requested in fact finding meetings.
7. Leads process robustness initiatives to optimize process control, productivity, and product quality and communicates findings to other functional areas.
8. Updates, reviews, and approves area procedures to assure correct content and compliance with Good Manufacturing Practices.
9. Initiates and leads project change proposals driven pertaining to drug product manufacturing, as required.
10. Participates in the identification of product processing issues and performs investigations to correct and prevent re-occurrence.
11. Manages and resolves operational and technical issues through effective communication and/or escalation within technical, operations and other support departments.
12. Performs other duties as assigned to support processing operations from a technical standpoint.
MINIMUM REQUIREMENTS
• BS in Engineering, Sciences, Information Systems or Statistics-related field
• At least one (1) year experience analyzing data in an pharmaceutical, lyophilization or parenteral manufacturing environments
• Ability to analyze data and detect trends and inconsistencies and to interpret trending situations based on data
• Knowledge in pharmaceutical, lyophilization or parenteral manufacturing processes
• Knowledge of FDA regulatory requirements and relevant governmental regulations, cGMPs, pharmaceutical business processes
• Ability to review SOPs and work instructions, guidelines pertaining to a pharmaceutical manufacturing plant
• Ability to write technical reports pertaining data analyses and trending data and ability to effectively present them
• Ability to interact effectively with people to establish and maintain excellent working relationship with at all organizational levels
• Ability to plan and prioritize multiple complex activities simultaneously and make decisions while balancing speed, quality and risk
• Capability to challenge the status quo to simplify work
• Bilingual English/Spanish, both written and verbal
• Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*