Specialist Manufacturing-33488

September 10, 2024

ProQualityNetwork

Job Opportunity: Specialist Manufacturing 33488

Location: Juncos, PR

Shift: 8:00 AM to 5:00 PM (Administrative Shift)

Position: 1

Work Type: 100% Onsite

Duration: Approximately 1 year

SUMMARY

With minimal supervision, this role supports the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. You’ll apply your process, operational, and scientific expertise, along with basic compliance knowledge, to provide analytical and troubleshooting support for manufacturing operations. You may serve as the primary production process owner and assist with more complex process systems.

Preferred Qualifications

Documentation: Procedure Revision
️ QMTS Trackwise
✅ CAPA’s
Manufacturing Process
Audits
Laboratory Knowledge

KEY RESPONSIBILITIES

️ Applied Process Expertise

✍️ Initiate, revise, and approve manufacturing procedures, ensuring all are up-to-date. Serve as a document owner.
Assess process performance by observing floor operations and reviewing performance data. Identify and implement process improvement opportunities.
️ Provide troubleshooting support.
Assist in creating training materials and may help deliver training on the scientific or technical aspects of processes.

Process Monitoring

Support the establishment of process monitoring parameters and control limits. Collect and assess process-monitoring data and deviations.
Contribute to the timely execution of quarterly process monitoring reports.

️ Non-Conformance & CAPA

️ Ensure that all non-conformances are triaged within the established time goals.

Author investigation reports and execute corrective actions.
✅ Manage non-conformance/CAPA closure within established timelines and monitor incident trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.

✅ Process Validation

Assist in generating process validation protocols and reports, as well as executing process validation tasks.
Support the collection and analysis of process validation data.

Regulatory

️ Participate in regulatory inspections as needed.

New Product Introductions & Equipment Modifications

️ Participate in the NPI process, assessing documentation, materials, training, and equipment modification requirements.
Provide project management and implementation support for process or equipment modification projects.

Change Control

Assist in managing change control packages that impact the process.

Projects and Initiatives

Participate in the assessment and implementation of special projects or initiatives.
Additional duties may be assigned.

EDUCATION & EXPERIENCE REQUIREMENTS

Doctorate Degree OR
Master’s Degree with 3 years of Manufacturing Operations experience OR
Bachelor’s Degree with 5 years of Manufacturing Operations experience OR
Associate’s Degree with 10 years of Manufacturing Operations experience OR
High School Diploma / GED with 12 years of Manufacturing Operations experience.

CORE COMPETENCIES & SKILLS

️ In-depth technical understanding of bioprocessing unit operations.

✅ Proficient in GMP production operations.
Familiarity with regulatory knowledge and processes.
Ability to participate and help lead cross-functional teams.
Strong communication and collaboration skills with technical and management staff across manufacturing, process development, and quality departments.
️ Excellent organizational, technical writing, and presentation skills.
Basic project management skills.
Working knowledge of control charting.

Ready to make a difference?

Send your updated resume to careers@proqualitynet.com with the subject line: Specialist Manufacturing 33488. We can’t wait to see how your skills will contribute to the success of our client’s projects!

We regret to inform you that this job opportunity is no longer available