Job Description
Job Description
Specialist Manufacturing (3524445) – Regulated Industry
Open to Puerto Rico Residents
100% Onsite Work – 8-Hour Shifts
Positions: 1
Period: Approximately 5 months
Contracted by: ProQuality Network
Summary
Our client is seeking a Specialist Manufacturing professional to support manufacturing and quality systems in a regulated environment. Under minimal supervision, the selected candidate will assist with non-conformances, process validation, procedure management, training, and new product introductions. The role requires application of operational, process, scientific, and analytical expertise, along with compliance knowledge and troubleshooting skills. The individual may serve as primary production process owner for process support systems and assist with process ownership for more complex operations.
Preferred Qualifications
- Experience with Veeva, TrackWise, CAPA, and Change Control
Key Functions
Applied Process Expertise
- Initiate, revise, and approve manufacturing procedures, ensuring alignment with current operations. Serve as a document owner.
- Assess process performance through floor observations and performance data review; plan and implement process improvement solutions.
- Provide troubleshooting support for manufacturing operations.
- Assist in generating training materials and support training on scientific or technical aspects of the process.
Process Monitoring
- Support the establishment of process monitoring parameters and control limits.
- Collect and analyze process monitoring data and assist in evaluating deviations.
- Support the timely execution of quarterly process monitoring reports.
Non-Conformance and CAPA
- Ensure all non-conformances (NCs) are triaged within established goals.
- Author investigation reports and execute corrective and preventive actions (CAPAs).
- Manage NC/CAPA closures within defined timelines and monitor incident trends.
- Review equipment/system root cause analyses and support trend evaluations.
Process Validation
- Assist in generating process validation protocols and reports.
- Support execution of process validation activities and collection of validation data.
- Participate in analysis of process validation results.
Regulatory Support
- May participate in regulatory inspections and audits as required.
New Product Introductions & Process/Equipment Modifications
- Participate in NPI processes to assess documentation, material, training, and equipment requirements.
- Support assessment, prioritization, and project management for process or equipment modifications.
Change Control
- Assist manufacturing change owners in review and implementation of CCRB packages impacting the process.
Projects and Initiatives
- Participate in special projects or continuous improvement initiatives as assigned.
Other functions may be assigned as required.
Education / Licenses
- 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
Competencies / Skills
- Detailed technical understanding of bioprocessing unit operations
- Skilled in GMP production operations
- Knowledge of regulatory requirements and inspections
- Ability to participate in and help lead cross-functional teams
- Strong communication, collaboration, and organizational skills
- Competent in technical writing and presentations
- Basic project management experience
- Fundamental understanding of control charting
Interested candidates are invited to apply through the job description link with an updated resume to be considered for this contract opportunity with ProQuality Network.