Compliance Specialist III at Apex Systems in Framingham, MA

Apex Systems

Framingham, MA
October 27, 2020
FULL TIME
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Compliance Specialist III

Compliance Specialist III Opportunity in Framingham, MA!
Apex Systems, the nation's 2 nd largest IT Staffing firm, has multiple opportunities for qualified candidates to join the team of a reputable organization in the Pharmacutical space!
If interested in this Compliance Specialist III role, or any other opportunity in the Greater Boston area, please send a resume to Allison Portnoy, Technical Recruiter, Job Title Compliance Specialist III Apex Job Number 1084898 Duration 4 Month Contract to Hire Location Framingham, MA Core Responsibilities include bull Function as shift lead including developing junior employees bull Perform batch record review bull Perform review of column packing and qualification records bull Review and sign-off on manufacturing supervisor notes bull Review and approve CRs related to EBRs (as applicable) bull Function as SME on challenges related to production requiring a quality input bull Non-conforming material discard bull Perform log book review bull Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps bull Issue action notices and conduct affiliated provisional release bull Conduct log book audits against compliance requirements bull Review CV related documentation against specification, Perform Bulk Raw Material Release bull Perform media buffer and intermediate release bull Perform release of Cell Banks for forward processing (as applicable) bull Support cross-functional internal audit activities and conduct walkthrough inspections bull Function as department lead for internal audits bull Function as CAPA owner bull Execute containment activities bull Provide expertise during procedureSOP revision process and function as DCR approver for department related SOPs and PRs bull Function as document owner as needed bull Maintain a high level of personal compliance to the required standards bull Partner with manufacturing and support operations to ensure a culture of continuous compliance bull May provide training to new employees bull Review of Quality Critical Alarms and NRSR bull Initiate and investigate and QA review deviations bull Provide off-hour support for batch record and log book issuance Represent for QA Ops for various projects (e.g.
CCR FMEA, Risk Assessment, RCA). bull Function as back-up for QA Manager Preferred Qualifications bull Bachelor's degree in a scientific field with 6+ years of experience in a Quality and or cGMP environment. bull 4+ year's experience in a Quality Assurance role. bull Experience in bio-pharmaceutical industry. bull Capable of analyzing trends and metrics that lead to improvement. bull Strong technical writing skills. bull Effective time management, attention to detail, organizational skills, teamwork and collaboration. bull Significant capability in problem solving methodology. bull Experience working in an environment of operational excellence. bull Experience training and developing employees. bull Experience participating in external agency inspections. bull Knowledge of regulatory enforcement trends. bull Ability to work independently.
Special Working Conditions bull Ability to gown and gain entry to manufacturing areas bull Ability to work a 12-hour rotating shift and every other weekend, including some holidays bull Ability to lift 10 lbs.
EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or

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Job Expires: November 26, 2020

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