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Associate Director, Quality Assurance

Company: NEW ENGLAND AD-CTR
Location: Salem
Posted on: September 13, 2020

Job Description:

Associate Director, Quality Assurance - Salem, NH Company: Boston Analytical

Location: Salem

Posted on: August 20, 2020

Job Description:

Associate Director, Quality Assurance - Salem, NH

Boston Analytical is a premier cGMP compliant laboratory, FDA &DEA registered, ISO/IEC-17025:2005 certified for pharmaceuticalanalytical testing. We provide the highest quality analyticaltesting services to Pharmaceutical, Biopharmaceutical, and MedicalDevice companies worldwide. Since 1987, Boston Analytical has beenand remains dedicated to customer satisfaction, and to the fast andaccurate analysis of our clients' products.

JOB SUMMARY

The Quality Assurance Associate Director is responsible forimplementing and maintaining laboratory quality systems andprocedures in compliance with all current FDA GMP regulations andguidance, as well as relevant ICH guidelines. This individual willoversee the Quality Assurance operations, quality systems andtraining program, and provide expertise and direction in relationto quality initiatives.

PRIMARY DUTIES AND RESPONSIBILITIES

• Responsible for the day-to-day and strategic functions of theQuality Assurance Department, including mentoring and supervisingQuality Managers, developing individual/departmentgoals/objectives, continually monitoring performance/conductingperformance reviews, and ensuring the development of a functionallycross-trained organization.

• Serve as a liaison between clients and the laboratory, inorder to effectively communicate quality procedures andsystems.

• Effectively refine/direct/manage the Change Controlprogram.

• Serve as a liaison for Boston Analytical inspections,including those conducted by clients, and inspections conducted byFDA or other regulatory authorities.

• Effectively create, approve, and direct the maintenance of allquality documentation, including Standard Operating Procedures.

• Manage and maintain a comprehensive CAPA program.

• Develop a system for surveillance inspections of auditedprojects for conformance to company and customer requirements.

• Work closely with other departmental leadership to achievecorporate and quality objectives.

• Provide management support for compliance activities asneeded.

REQUIREMENTS & QUALIFICATIONS

Qualification include a degree in Chemistry or a related scienceis required with a minimum of 10 years of experience in apharmaceutical quality assurance management role. Experience in FDAcGMP regulated analytical and/or microbiological laboratorysettings. Fluent in current Agency guidance and ICH guidelines asthey relate to cGMP operations, as well as demonstrated success inimplementing systems complaint with these regulations andguidelines.

MINIMUM SKILLS REQUIREMENTS

• Extensive knowledge in FDA cGMP regulations and currentindustry practices.

• Demonstrated ability to mentor/manage/lead Quality Assurancepersonnel.

• Ability to multi-task and meet deadlines.

• Knowledge of the regulations of the Food and DrugAdministration, compliance with Good Manufacturing Practices andpharmaceutical analyses is required.

• Must have the ability and skill to perform the detailed jobrequirements noted above competently, safely and proficiently.

• A self-starter, motivated person who possesses goodinterpersonal skills capable of effectively interacting with alldepartments and client personnel.

• Must have excellent organizational, verbal communication andtechnical documentation skills.

• Must be a team player with integrity and concern for thequality of Company products, services and staff members.

Boston Analytical is a growing pharmaceutical contract labproviding quality Analytical and Microbiological testing services.We are known for our quality and believe our success is driven byour employees. We provide our employees with a state-of-the-artwork environment, excellent benefits and opportunities fordevelopment.

Job Requirements:

Related Keywords:

Associate Director, Director, QA, Quality Assurance, Laboratory,Pharma, Pharmaceutical, GMP, Boston Analytical, New Hampshire, NH,Salem, Science, Management, Leadership, SOPs

Keywords: Boston Analytical, New England , Associate Director, Quality Assurance - Salem, NH, Other , Salem, Northeast

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Keywords: NEW ENGLAND AD-CTR, Salem , Associate Director, Quality Assurance, Other , Salem, Oregon

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