ISO Group

POSITION SUMMARY

Responsible for the QA verification audits as established by the Consent Decree-Work Plan verification requirements. The individual will be responsible for the handling and verification of the evidence package after the Quality System Element (QSE) team completes the work plan steps. The incumbent will support other associated tasks of the Consent Decree remediation plan, as well as other assigned tasks. This is a position within the Quality Organization. It requires effective communication, influencing and interdependent partnering skills to drive results and compliance across the site.

Responsibilities:

1. Conduct verification audits of the corrective actions for each Quality System Element as defined in the in CD Work Plan. The verification is required in four phases:

• Deliverables Concurrence: Concurrence between the three verification teams (McNeil, Enterprise Regulatory Compliance (ERC), and Quantic) on deliverables expected at end of the “in place” and “in use” phases.

• “In Place” Verification: Record and/or collection of records that document the completion of the deliverable.
i. Most likely a desk document review, but may be a shop floor activity

• “In Use” Verification
i. Record or collection of records that demonstrates sustainable compliance.
ii. May be a document review, shop floor review, and/or sampling of executed data.

• Holistic review of work plan steps in order to perform overall certification

 
2. Expedite the QA verification strategy in alignment with the Work Plan remediation:

3. Issue a report to the QA Site Management of any findings during the QA verification process.

4. Address McNeil findings until the work plan step is ready to proceed to ERC verification.

5. Inform ERC when the work plan step is ready for their verification to begin.

6. Participate with the QSE team in the ERC verification and Quantic verification reviews.

7. Collaborate with other compliance officers on events and issues.

8. Oversee completion of due diligence process for distributor and other Third Party management in cooperation with relevant business partners. Support external and internal audit preparation and management.

9. Will ensure allegations of non-compliance are investigated and responded to promptly.


Requirements:

1. Bachelor Degree in Science, Engineering or other technical discipline. Master Degree is preferred.
2. A minimum of eight years of experience in Compliance, Quality and/or Manufacturing Operations in the pharmaceutical manufacturing industry.
3. Knowledge with current US-GMPs and regulatory requirements for pharmaceuticals.
4. Experience with critical review of documentation content, (change controls, procedures (SOPs), validation/qualification protocols/reports)
5. Experience managing projects is desired.
6. Strong technical writing skills. Bilingual (English and Spanish).
7. Experience with Process Excellence/Six Sigma tools, training and/or certification is preferred.
8. Integrity and J&J Credo-based actions, strategic thinking, big picture orientation with hands on attention to detail experience, organization and talent development, intellectual curiosity, collaboration and teaming, sense of urgency, prudent risk-taking, self-awareness and adaptability, results and performance driven.
9. Able to travel in and outside of Puerto Rico.
10. Able to work extra hours and to respond to emergency calls that require returning to the company after regular working hours of the business.
11. Able to work special shifts, long hours and weekend hours

Are you a degreed engineer with hands-on process engineering experience?  Would you like to work in the rapidly growing medical device industry?  Would you like to live and work in one of the truly “cool” parts of the country?  If so, then do not miss out on this opportunity. The ideal candidate will possess strong communication skills, strong analytical skills, and a hands-on approach to problem solving and process improvement. This individual will interface with all levels of engineering, logistics, manufacturing and quality. This person will be responsible for process improvements and controls, machine capacity and capability studies including IQ/OQ/PQ.

Job Responsibilities

·         Work with customers and manufacturing to design tools, equipment, and processes to produce wire/ tube products

·         Constructively communicate with operators and other departments

·         Perform testing to determine properties, then develop repeatable processes based on the data

·         Apply statistical methods such as design of experiments,

 ·         Troubleshoot problems and define preventative and corrective actions

·         Thoroughly document tasks including creation of required prints, work instructions and specifications

·         Effectively present findings or oral arguments to customers and management when necessary

·         Self-starter and able to work under minimal supervision and guidance

Experience Requirements

·         BS or MS in engineering

·         At least 6 years experience as a process/ manufacturing engineer

·         Experience in Design of Experiments, Statistical Process Control, Project Planning, Process Engineering, ISO 9000 and/ or 13485

·         Knowledge and/ or experience with word processing spreadsheets, data bases and computer aided design software

·         Experience with shape memory alloys and/or nitinol experience

·         Knowledge of material science of metals including material properties and test methods

·         Experience with statistical methods, and DOE would be a plus

·         Experience with wire and tubing drawing methods

 Candidates willing to recolocalizarse for nine months !!

We are currently looking for a IQ Engineer for a medical device/instrumentation firm. In this role, you will actively support Quality Assurance, Engineering and Manufacturing with inspection, qualification, verification and validation activities.

The ideally qualified candidate will bring will have the following experience and Qualifications:
• Education: Bachelors’ Degree, technical degree preferred.
• Experience: 6 years’ experience working within a Quality/Validation role and working within the medical device discipline and software space.
• Those with direct experience complying with the Medical Device Directive, and FDA QSR.
• Prior experience with risk analysis, statistical techniques, SPC experience is preferred but not a MUST have.

This position will:
• Develop Quality Plans, generate and support IQ/OQ/PQ and validation protocols and reports.
• Review for completeness project plans, design control activities, labeling and technical documentation and Engineering Change Notices.
• Support Engineering and Manufacturing with testing activities to ensure product changes meet product and performance requirements.
• Analyze quality metrics to address process improvements with Manufacturing and Engineering.
• Assist with the development of and implementation of quality and manufacturing procedures.
• Develop and implement quality methods and equipment to improve effectiveness of test and inspection operations.
• Support new product development programs by providing input regarding Quality Assurance requirements early in the product development cycle.
• Work with all elements of Design Control, Process and Product Verification, Validation Testing including software validation, DMRs, and Risk Management.

Project nine months out of PR

Coordinate and follow up to the Quality System related to GMP, Security and environmental. Additional duties as required by the Engineering Department to support engineering Projects. Generate status report or Metric of the quality system of Engineering with the purpose to maintain the personnel informed, follow up on pending work and assure that they are completed under the determine time established. Prepare, revise and submit modification through EDM of the processes of standard operations SOP of Engineering and the appropriate documentation as required in the established time. Support maintenance supervisors in the gathering of data to close the document in the Quality System.

BA required. 1 to 3 years of experience in the pharmaceutical industry

Prepares and executes all protocols and reports for validation work. May coordinate all validation activities by constant communication with related departments and personnel; oversees and reviews validation area processes and procedures. May require a bachelor’s/master’s degree in engineering and 2-5 years of experience in the field or in a related area. Familiar with standard concepts, practices, and procedures within a particular field. Eight (8) years experience.

If you meet all of the above requirements and want to explore an opportunity with ISO Group, please submit your resume via email to: drodriguez@isogrouppr.com, att. Desirée Rodríguez, Recruitment & Human Resources Manager

1. Verifies regulatory commitments compliance to Comprehensive Action Plan requirements.
2. Design strategies as needed to meet regulatory commitments.
3. Participates in activities leading to commitment completion as necessary.
4. Interprets and communicates the CAP and CD commitments to key stakeholders.
5. Interacts with site and Home Office personnel as it relates to commitment tracking and completion.
6. Provides support during audits of regulatory agencies and external entities.
7. Acts with discretion and independent judgment.
8. Prepares and publishes periodic reports related to the Comprehensive Action Plan and CD commitments.
9. Prepare and analyze documents/protocols as it relates to the completion of the CAP and CD commitments.
10. Notification to Management of any missed commitments and/or incomplete commitments as a result of the verification activities.

Education: Bachelor in Natural Science or Engineering. Experience: Eight (8) years of experience working in the Pharmaceutical industry, with five (5) years in the Regulations and Quality Assurance areas. Experience in handling regulatory agency audits, investigations, manufacturing processes and preparation of related reports. Knowledge, Skills and Abilities: Bilingual (English/Spanish-oral and written). Knowledgeable in cGMPs (CFR Part 11, 210 and 211) and other pharmaceutical industry applicable regulations. Computer literate. Good oral presentation techniques and writing skills.

drodriguez@isogrouppr.com

Equipment/Maintenance Engineer with 10+ years experience in the Pharmaceutical Industry to support the review and assessment of manufacturing and packaging process equipment qualifications, system specifications, critical equipment parameters/settings/ranges and operational compliance requirements. Role will also support the review and assessment of cleaning procedures and operational guidelines/procedures across multiple sites. Knowledge of current Good Manufacturing Practices and Regulatory guidelines for Pharmaceutical Industry.

Bachelor’s Degree Engineering
Degree Engineering
Experience: 10+ years Equipment/Maintenance Engineer Experience in Pharmaceutical Industry
Experience with writing and reviewing qualification/validation documents (reports, papers, procedures, batch records, other)
Experience with Quality Systems, Quality Standards and Regulatory Documents
Bi-lingual preferred (Spanish & English) Knowledge,Skills and Abilities:MS Office Skills… Word, Excel and Visio,Ability to drive action
Technical knowledge of equipment validation/qualification processes, procedures and documentation.Demonstrated ability to deliver projects on time and within budget – project managements skills,Strong written and oral communication skillsAbility to gather information, analyze and develop tactical plan,Acts decisively, setting clear goals and objectives,Demonstrated collaboration skills in a team environment.

Responsible for successfully leading project teams, developing project scope, user requirements, time-lines and budgets, validation plans, and approproation request; generating equipment,facility and system specification and documentation to meet current company, corporate and goverment requirements; and managing the purchase, installation and star-up of equipment and systems. Responsible for supporting utilities and facilities ans construction needs; ensure incorporation of regulatory compliance requirements (GMP<FSA,safety,environmental).BS Degree in Chemical/Mechanical Engineering.
Experence: 10 years of experience working in a manufacturing or engineering atmosphere, prefeably with experience in one or more of the following disciplines: Manufacturing Operations, Projects, Validation, Technology Transfer or the equivalent. Ability to advise, calculate, categorize, classify, compare, coordinate,detec diagnose, edit, estimate, evaluate, interview, influence. Ability to establish positive interperssonal relationships and interact with people effectively, work under a lot of time pressure and make decisions accordingly. Should be able to take initiave and make good judgment in the performance of his/her duties. Bilingue. Knowledgeable in statistics, GMP, and phamaceutical industrial aplicable regulations. Ability to manage broad projects integrating phamarceutical unit operations, processes, equipment, utilities, and facilities.

If you meet all of the above requirements and want to explore an opportunity with ISO Group, please submit your resume via email to: drodriguez@isogrouppr.com, att. Desirée Rodríguez, Recruitment & Human Resources Manager

A minimum of a Bachelors degree is required.  A focused degree in chemistry, microbiology, or science discipline is preferred.  A minimum of 8 years experience in process validation, formulations development, process engineering is required.  Experience in the Pharmaceutical industry is required.   Experience in a Solids/ liquids manufacturing plant preferred.  Experience working and leading a cross-functional team is required.  Experience working within a strictly regulated GMP and FDA regulated environment is required.  Experience with Six Sigma Process Excellence tools, training and/or certification is a plus. Experience with quality systems and investigations is required.  Experience with documentation and technical writing skills, in a regulated compliance environment, is preferred.  Strong influencing, negotiations and leading without direct line authority experience is required.  The ability to manage complexity and manage a diverse team is critical.  Excellent written and oral communication skills in English and Spanish are required. This position may require up to 25% travel domestically. 

Reliability Engineer :

Analyze Manufacturing Processes (Granulation), Compression, Coating & Printing), Utilities or facilities
Strong Knowledge of Granulation, Compression and Coating & Printing equipment.*Experience conducting and developing Commissioning and Qualifications *Cleaning Validation *Experience determine Criticality *FMEA and RPN knowledge *GMP and Compliance Experience is a must *Ris…k Assessment and Risk analysis. *DQ, IQ, OQ or PQ Preparing and executing *Consent Decree is a plus *Project Management experience *Flow Diagram Processes *Six sigma training *Fully Bilingual (English/Spanish) *Supervisory experience *People Skills and Influence Skills *Minimum BA in Eng 5+ years of related experience.

If you meet all of the above requirements and want to explore an opportunity with ISO Group, please submit your resume via email to: drodriguez@isogrouppr.com, att. Desirée Rodríguez, Recruitment & Human Resources Manager.