Remote Support Operations Jobs – Salary $65,000–$115,000

By / June 8, 2026
final answers Corp. is a depended on provider of packaging business automation, serialization and compliance for the existence technological know-how Industries in Puerto Rico, u.s.a. and Europe. Over a decade, the ultimate crew has deliver confirmed results in loads of tasks and lots of service hours to the worldwide leaders of pharmaceutical, biotechnology, medical devices and logistics markets.

DESCRIPTION
below the direction of the Operations supervisor/Director, behavior and offers technical management towards the identification of the causes for non-conformances and method, failures and for the implementation of the remedial, corrective and preventive actions thus assuring manner performance and compliance in opposition to site QSR, GMP and ISO necessities for the complete fee circulate manufacturing tactics. accountable for overseeing the Non Conformance report (NRs) and Corrective motion and preventive motion (CAPA) and Audit Observations.
Adheres to environmental policy, procedures, and supports department environmental objectives.

education
Bachelors degree in science or Engineering is required
minimal of 2 years of experience in regulated enterprise, scientific device operation favored.
robust know-how of FDA 21 CFR and worldwide clinical device policies and requirements is required (consisting of however not constrained to MDD, MDR rules, worldwide requirements ISO 13485, ISO 14971, JPAL, Canadian, and Brazil guidelines

necessities
Required understanding, skills, capabilities, Certifications/Licenses and Affiliations
Bilingual (Spanish & English)
must have thorough expertise in QSR, GMP, ISO, know-how in carried out facts and failure mode analysis techniques.
talented inside the coaching of technical reports and presentations.
requires sturdy conversation, interpersonal and negotiation abilties.
position requires leadership abilties, teamwork, initiative, creativity, assertiveness, and interest to element talents.
may also calls for operating / traveling all shifts and working abnormal hours.
applicants ought to be presently legal to work for any agency in the america on a complete-time unrestricted foundation. Employment visa sponsorship isn’t to be had.
no longer open for Corp-to-Corp arrangements

responsibilities
carry out the investigations in ETQ for NRs/CAPAs and Audit Observations for Operations.
Plan and execute product disposition, movements associated with NC/CAPA & Audit Observations.
close the investigations and Product inclinations on time.
Identifies and improve to Operations Managers/Director any compliance troubles and their capacity impact across the franchise in order that they may be efficiently resolved.
evaluations and analyses best tendencies with the manufacturing team. considering the exceptional traits offers path in terms of putting paintings priorities for technique enhancement.
provides steerage to manufacturing supervisors to make sure that effective in-depth investigations are carried out.
gives management and steerage to pass useful, multilevel technical teams to guarantee causes of non-conformance are recognized and understood and that sound corrective/preventive movements are applied. evaluation of the carried out corrective and preventive movements in opposition to tendencies to evaluate effectiveness of the equal.
Leads /support continuous development actions to get rid of, lessen or mitigate failure modes in manufacturing strategies.

remaining solutions Corp is an equal possibility corporation.

 

📅 Jun 8 Posts (199)

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