Abacus Service Corporation · 4 months ago
Analyst 2, Quality Assurance
Abacus Service Corporation is seeking an Analyst 2 for Quality Assurance. The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met.
Health CareInformation Technology
Responsibilities
Ensure quality and compliance in all my actions by:
Attend GMP training on the schedule designated for my role and as appropriate for my role
Adhere to strict compliance with procedures applicable to my role
Exercise the highest level of integrity in the tasks that I perform
In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace
Embrace a behavior of employee involvement and commitment to doing the job right the first time
Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year
Promote an environment of employee involvement in the workplace
Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees
Provides daily 'Shop Floor” QA support to warehouse, bulk manufacturing and packaging lines
Provides leadership support to QA Shop Floor activities including communication of quality events to management
Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases
Provides support to Investigations and/or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals
Performs or supports activities related Line Audits, Line or Area Cleaning Verifications
Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP's)
Provides support to Consumer Complaint investigations
Provide QA support to various project teams, as needed
Actively supports Site metrics, compliance improvement and training initiatives
Provide support to capturing of site metrics and promote improvement opportunities
Facilitate resolution of issues to improve site metrics
Provides training and direction as needed to new employees
Teams with Department members for process feedback and continuous improvement opportunities
Represents Quality Assurance in positive manner
Performs other related duties as required
Qualification
Required
Must be able to work four 10 hour days
Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines
Attend GMP training on the schedule designated for my role and as appropriate for my role
Adhere to strict compliance with procedures applicable to my role
Exercise the highest level of integrity in the tasks that I perform
In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace
Embrace a behavior of employee involvement and commitment to doing the job right the first time
Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year
Promote an environment of employee involvement in the workplace
Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees
Provides daily 'Shop Floor' QA support to warehouse, bulk manufacturing and packaging lines
Provides leadership support to QA Shop Floor activities including communication of quality events to management
Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases
Provides support to Investigations and/or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals
Performs or supports activities related Line Audits, Line or Area Cleaning Verifications
Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP's)
Provides support to Consumer Complaint investigations
Provide QA support to various project teams, as needed
Actively supports Site metrics, compliance improvement and training initiatives
Provide support to capturing of site metrics and promote improvement opportunities
Facilitate resolution of issues to improve site metrics
Provides training and direction as needed to new employees
Teams with Department members for process feedback and continuous improvement opportunities
Represents Quality Assurance in positive manner
Performs other related duties as required
Drug testing is required for this position
Company
Abacus Service Corporation
Abacus Service Corporation is provides IT solutions for global health care businesses.
H1B Sponsorship
Abacus Service Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (2)
2022 (2)
2021 (4)
2020 (4)
Funding
Current Stage
Growth StageCompany data provided by crunchbase