Cambrex High Point Quality Specialist I 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.
The QA Specialist I supports the Quality Management System (QMS) and the Document Management System (DMS) in a GMP regulated environment according to established operating procedures. The QMS and DMS functional areas include but are not limited to: Document Control, Training, Deviations, Out of Specification Investigations, Corrective and Preventive Actions (CAPA), Change Control, Complaints, Quality review of analytical and microbiological data and batch production records, Internal Audits, Supplier/Subcontractor Management, Validation, and Calibration & Maintenance.
Provides quality evaluation and release of support materials, products, equipment and facilities
Maintains quality databases and may perform analysis and trending
Assists with quality improvement initiatives as needed
Supports the DMS including revising and effective dating documents, assisting with training curriculums and providing end user support.
Performs internal audits
Maintains working knowledge of regulations
Analyzes information for accuracy and compliance to internal procedure, cGMP and other regulatory guidelines.
Controlled document and record review, e.g. SOP, validations, analytical test records
Review of master batch records and executed batch records
Effectively performs a variety of duties on schedule, with accuracy and competency
Maintains accurate files and records
Complies with company policies and SOPs; performs assigned tasks carefully and on schedule according to SOPs.
Performs other duties as assigned
Related BA/BS degree with 0-2+ years experience or equivalent.
Communicate clearly and effectively both orally and in writing with clients and other employees.
Goal-oriented, with ability to prioritize and manage multiple tasks and numerous projects in a fast-paced environment.
Strong problem-solving abilities.
Good understanding of GMP / GLP policies and regulations
Knowledge of basic concepts, practices and procedures
General knowledge of chemistry and scientific calculations
Must have understanding of Quality Management Systems
Good skills with MasterControl and/or DMS applications
Technical experience and knowledge in developing documentation workflows
Working knowledge and understanding of software validation principles
Good knowledge of regulations and SOP’s applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
Basic computer skills
Ability to take direction from others and contributes in a team environment
Attention to detail
Ability to review, compile, and analyze information to prepare reports
Good interpersonal skills and is willing to ask questions about procedures and concepts
Aptitude and willingness to gain more skills and knowledge
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/1915/quality-specialist-i/job?mode=apply&apply=yes&in_iframe=1&hashed=-336240429)
Type Regular Full-Time