Operations Support Specialist

Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has deliver proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.

DESCRIPTION

Under the direction of the Operations Manager / Director, conduct and provides technical leadership towards the identification of the causes for non-conformances and process, failures and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Site QSR, GMP and ISO requirements for the entire Value Stream manufacturing processes. Responsible for overseeing the Non Conformance Report (NRs) and Corrective action and preventive action (CAPA) and Audit Observations.

Adheres to environmental policy, procedures, and supports department environmental objectives.

EDUCATION

Bachelors Degree in Science or Engineering is required

Minimum of 2 years of experience in regulated industry, medical device operation preferred.

Strong knowledge of FDA 21 CFR and global medical device regulations and standards is required (including but not limited to MDD, MDR Regulations, International standards ISO 13485, ISO 14971, JPAL, Canadian, and Brazil Regulations

REQUIREMENTS

Required Knowledge, Skills, Abilities, Certifications / Licenses and Affiliations

Bilingual (Spanish & English)

Must have thorough knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques.

Proficient in the preparation of technical reports and presentations.

Requires strong communication, interpersonal and negotiation skills.

Position requires leadership skills, teamwork, initiative, creativity, assertiveness, and attention to detail skills.

May requires working / visiting all shifts and working irregular hours.

Applicants must be currently authorized to work for any employer in the United States on a full-time unrestricted basis. Employment visa sponsorship is not available.

Not open for Corp-to-Corp arrangements

RESPONSIBILITIES

Perform the investigations in ETQ for NRs / CAPAs and Audit Observations for Operations.

Plan and execute product disposition, actions related to NC / CAPA & Audit Observations.

Close the investigations and Product Dispositions on time.

Identifies and escalate to Operations Managers / Director any compliance issues and their potential impact across the franchise so that they can be effectively resolved.

Reviews and analyses quality trends with the manufacturing team. Considering the quality trends provides direction in terms of setting work priorities for process enhancement.

Provides guidance to manufacturing supervisors to ensure that effective in-depth investigations are performed.

Provides leadership and guidance to cross functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective / preventive actions are implemented. Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.

Leads / support continuous improvement actions to eliminate, reduce or mitigate failure modes in manufacturing processes.

Ultimate Solutions Corp is an equal opportunity employer.