Company Information
You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
* engage in work that matters to our customers and the patients they serve
* learn new skills and enjoy new experiences in an engaging and safe environment
* strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
The Quality Technician is responsible for verifying that quality is being maintained throughout the stability storage and sample management process.
Responsibilities
Specific responsibilities include but are not limited to:
QMS:
* Provision of assistance and advice to the Company on all QMS activities.
* Ensure that all Q1 activities meet the quality standards specified by the Company QMS and in accordance with cGMP standards.
* Continually monitors the QMS system suggesting improvements and CAPA measures.
* Administration of quality manuals, continuous improvement initiatives & interaction with management personnel on quality initiatives.
* Ensure all planned and unplanned changes (deviations) are adequately investigated and documented.
Audits:
* Ensure compliance to GMP certification by conducting and reporting internal reviews.
* Co-ordinates, prepares and is the lead for all internal, regulatory, supplier and customer audits.
Operational Activities:
Administration of quality documents, continuous improvement initiatives and interaction with management personnel on quality issues to include but not limited to:
* Providing admin assistance to the Company on all QMS activities issuing controlled documents (logbooks, protocols for execution, etc.).
* Maintenance of indexes
* Issue of document numbers.
* Review of completed documents for compliance to specification and to ensure all entries are complete.
* Proposing/reviewing document changes as appropriate.
* Performing daily checks on stability cabinets/room conditions as appropriate (in the absence of Operations).
* Providing support as required for checking of samples on receipt at Q1 Scientific/on return to Client as appropriate.
* Reviewing calibration and temperature mapping activities
Qualifications/Skills
This is not an exhaustive list of duties, and you will be expected to perform different tasks as necessitated by your changing role within the organisation and the overall business objectives of the organisation.
Education, Experience & Licensing Requirements
* Primary degree preferable but not essential
* Experience in working in a regulated environment
* 2-3 years experience in QA
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.
Travel: Not applicable
Physical Demands
The physical demands described here are representative of those that must be met by an employee
to successfully perform the essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to use hands to finger,
handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently
required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or
crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move
up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities
required.
Environment and Protective Equipment
The work environment characteristics described here are representative of those an employee
encounters while performing the essential functions of this job. Reasonable accommodations may
be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is occasionally exposed to moving mechanical
parts and vibration. The noise level in the work environment is usually very quiet.
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