QA Specialist I - Audits


LSNE Contract Manufacturing


Posted Under: Bedford, New Hampshire jobs in Accounting, Auditing; Accounting, Auditing jobs in zipcode 03110
Posted On: 2019-01-10

JOB SUMMARY This position is responsible for maintaining and adhering to LSNE and regulatory compliance requirements for established quality system programs by performing internal audits, hosting client audits and providing assistance during regulatory agency inspections. Additionally, this position plays a key role in maintaining the Material and Supplier Qualification programs for all LSNE facilities. JOB DUTIES -* Responsible for maintaining the Internal Audit Program and Supplier / Material Qualification Program by performing internal and supplier audits to evaluate compliance to standard operating procedures, quality and regulatory standards and is responsible for creating and issuance of audit reports* Responsible for follow up and tracking of internal and supplier audit observations to assure timely closure* Assist with monitoring and communication of supplier change notifications and communication with suppliers for non-conformance and complaint handling* Assist with scheduling and hosting client audits and coordinating audit responses for any deficiencies from internal stakeholders* Responsible for reviewing all audit responses to assure non-recurrence of deficiencies* Provides assistance to others as needed with tasks that require a better understanding of quality systems* Maintain, trend, analyze and report quality metrics as it relates to internal, supplier and client audits* Drafting, review and management of supplier quality assurance agreements (QAA's) and non-disclosure agreements* Provide support for Quality Council meetings* Provides support during FDA and other regulatory agency inspections* Facilitate internal training on GMP and regulatory requirements, processes and procedures as needed* Complete assignments with minimal supervision and works independently with minimal direction* Writes and revises QA Standard Operating Procedures (SOP) under minimal supervision* Support continuous improvement initiatives under minimal supervision* Performs other duties as assigned EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE -* Exceptional organizational skills* Detail oriented and a results driven team player* Experience working with cross-functional teams, including giving training and/or presentations to large groups* Excellent interpersonal skills and the ability to communicate well orally and in writing* Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is a must* Thorough working knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) Guidance's, and ICH is required; EMEA and other agency regulations is a plus* Ability to multi-task in a dynamic environment with changing priorities* Ability to meet challenging timelines, think strategically and tactically, balancing workload changes* Proficiency in MS Office including Word, Excel, Access and Visio* Excellent verbal and written communication skills required* Auditing certification preferred (i.e., ASQ, CQA or similar)* High School Diploma/Associates Degree with 10+ years' experience in a QA GMP environment;* Bachelor's Degree preferred with 5-10 years' experience in a QA GMP environment; Master's Degree with 1-5 years' experience in a QA GMP environment PHYSICAL REQUIREMENTS -* Frequent reading, writing, and verbal communication* Must be able to travel between multiple production facilities* Ability and willingness to travel at least 15%-20% of time is required (domestic and/or international) COMMUNICATIONS & CONTACTS -* Interacts with all departmental staff, external clients and suppliers

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