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Cambrex High Point Quality Assurance Manager in Agawam, Massachusetts

 

At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings!Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

The Manager of Quality Assurance supervises and coordinates the activities of assigned Quality area (i.e. Technical Review, Compliance ) and provides technical leadership for the assigned team. The Manager ensures all QA activities are in compliance with company SOPs, GMP standards and FDA/EU and ISO 17025 regulations. This role will interact with clients and is responsible for successfully meeting client and departmental objectives in a timely manner.

Responsibilities

  • Ensure compliance for all QA activities by working with external groups, labs, and vendors to ensure timely testing and compliant documentation in support of material and product

  • Supervises the day to day operations for assigned

  • Ensures all staff members are fully

  • Participates in and supports client visits, audits and inquiries to ensure complete fulfillment of requests and

  • Recruits, trains, develops and retains staff for the effective process of departmental

  • Provides technical guidance for troubleshooting and investigating simple to moderately complex issues in area of expertise.

  • Applies statistical analysis for interpretation of project

  • Ensures all CGxP data generated for projects are managed and evaluated as described in relevant internal procedures and regulatory

  • Effectively resolves quality issues and concerns in a timely

  • Enforces all laboratory safety, security and housekeeping policies and

  • Actively contributes to the preparation and coordination of internal audits and regulatory

  • Creates strong and effective relationships with

  • Maintains a high level of professional and technical expertise through familiarity with scientific literature, conference attendance, and participation in training

Qualifications

  • Requires a life science degree and at least 4+ years of relevant QA/ Operations experience within the CDMO or Pharmaceutical And 6+ years in leadership roles.

  • Proven ability to work with site Quality and Operation teams to build and standardize quality systems across sites.

  • Good analytical and problem-solving skills, with the ability to think

  • Strong attention to detail, as well as time and resource management.

  • Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.

  • Promote a safe environment for

  • Comply with the general policy of the

  • Communicate well orally both for

  • Internal customers and team members

  • External customers

  • Ability to write reports and business

  • Ability to listen and respond well to external customers, partners and colleagues at all

  • Staff may include salaried and/or hourly non-exempt employees. Expected to coach, train and develop skills of the subordinate

  • Good team and interpersonal skills

  • Understands how to prioritize tasks according to business objectives and can pursue several objectives

  • Tackles problems with enthusiasm and

  • Ability to listen and respond well to external customers, partners and colleagues at all

  • Highly effective team and interpersonal skills with the ability to work across numerous management

  • Highly goal and result

  • Can work independently with a high degree of self-motivation.

  • Treats colleagues at all levels with

  • Very effective listening skills with the ability to hear attentively and process information

    Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. (https://careers-cambrex.icims.com/jobs/1971/quality-assurance-manager/job?mode=apply&apply=yes&in_iframe=1&hashed=-336240429)

Job LocationUS-MA-Agawam

Type Regular Full-Time

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