Specialist Manufacturing-33488
π Job Opportunity: Specialist Manufacturing 33488 π
π Location: Juncos, PR
β° Shift: 8:00 AM to 5:00 PM (Administrative Shift)
πΌ Position: 1
π’ Work Type: 100% Onsite
π 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. Youβll apply your process, operational, and scientific expertise, along with basic compliance knowledge, to provide analytical and troubleshooting support for manufacturing operations. π You may serve as the primary production process owner and assist with more complex process systems.
π― Preferred Qualifications
- π Documentation: Procedure Revision
- π οΈ QMTS Trackwise
- β CAPAβs
- π Manufacturing Process
- π Audits
- π¬ Laboratory Knowledge
π KEY RESPONSIBILITIES
π οΈ Applied Process Expertise
- βοΈ Initiate, revise, and approve manufacturing procedures, ensuring all are up-to-date. Serve as a document owner.
- π Assess process performance by observing floor operations and reviewing performance data. Identify and implement process improvement opportunities.
- π οΈ Provide troubleshooting support.
- π Assist in creating training materials and may help deliver training on the scientific or technical aspects of processes.
π Process Monitoring
- π₯ Support the establishment of process monitoring parameters and control limits. Collect and assess process-monitoring data and deviations.
- π Contribute to the timely execution of quarterly process monitoring reports.
β οΈ Non-Conformance & CAPA
- β±οΈ Ensure that all non-conformances are triaged within the established time goals.
- π Author investigation reports and execute corrective actions.
- β Manage non-conformance/CAPA closure within established timelines and monitor incident trends.
- π Review equipment/system Root Cause Analysis investigations and support trend evaluations.
β Process Validation
- π Assist in generating process validation protocols and reports, as well as executing process validation tasks.
- π Support the collection and analysis of process validation data.
π Regulatory
- π©ββοΈ Participate in regulatory inspections as needed.
π New Product Introductions & Equipment Modifications
- π οΈ Participate in the NPI process, assessing documentation, materials, training, and equipment modification requirements.
- π Provide project management and implementation support for process or equipment modification projects.
π Change Control
- π Assist in managing change control packages that impact the process.
π Projects and Initiatives
- π Participate in the assessment and implementation of special projects or initiatives.
- Additional duties may be assigned.
π EDUCATION & EXPERIENCE REQUIREMENTS
- π Doctorate Degree OR
- π Masterβs Degree with 3 years of Manufacturing Operations experience OR
- π Bachelorβs Degree with 5 years of Manufacturing Operations experience OR
- π Associateβs Degree with 10 years of Manufacturing Operations experience OR
- π High School Diploma / GED with 12 years of Manufacturing Operations experience.
π§ CORE COMPETENCIES & SKILLS
- βοΈ In-depth technical understanding of bioprocessing unit operations.
- β Proficient in GMP production operations.
- π Familiarity with regulatory knowledge and processes.
- π₯ Ability to participate and help lead cross-functional teams.
- π¬ Strong communication and collaboration skills with technical and management staff across manufacturing, process development, and quality departments.
- ποΈ Excellent organizational, technical writing, and presentation skills.
- π Basic project management skills.
- π Working knowledge of control charting.
ο»Ώπ§ Ready to make a difference?
π Send your updated resume to careers@proqualitynet.com with the subject line: Specialist Manufacturing 33488. We canβt wait to see how your skills will contribute to the success of our clientβs projects! π