QA Specialist I - Agawam, United States - Cambrex
Description
Overview:
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.
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/external audits, supplier/subcontractor management, validation, and calibration & maintenance.
This role may participate in various aspects of technical data and documentation evaluation and review, manufacturing operations, laboratory operations, investigations, and a variety of routine and nonroutine tasks.
Responsibilities:
- Responsible for performing an independent quality evaluation and release of support documentation, materials, products, equipment, and/or facilities.
- Ensure all testing/manufacturing was performed per approved SOPs/methods/protocols and comply with specifications by critically evaluating the reported data and results for accuracy and compliance with other regulatory guidelines.
- Under manager supervision, able to comply with GMP, SOPs and basic regulatory guidance.
- Participates in department/client meetings, collaborates, and cooperates to achieve crossfunctional improvements and business goals.
- Ability to participate in internal, client and/or regulatory audits. Works with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.
- Exercises judgment within defined procedures and practices to determine appropriate action (root cause analysis tools, CAPA, etc.) for quality events.
- Good interpersonal skills and willing to ask questions about procedures and concepts.
- Participates in the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site's needs.
- Effectively resolves quality issues and concerns in a timely manner.
- Effectively coordinates and organizes tasks to help drive the activities of the department; while performing a variety of duties on schedule, with accuracy and competency.
- Ability to take direction from others and contribute in a team environment.
Qualifications / Skills:
Knowledge
- 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 independently with mínimal direction.
- Promote a safe environment for work.
- Communicate clearly and effectively both orally and in writing with internal and external clients.
- Working knowledge and understanding of LIMS and Empower.
- Understanding of validation, production equipment, utilities, and/or drug development/manufacturing operations.
- Theoretical understanding and providing effective evaluation of laboratory practices such as raw material, drug substance, drug product and medical device testing, compendia methods (e.g. USP/NF, EP, JP), and method validation/qualification/transfer, as required.
Skills / Abilities:
- Demonstrate the capability for continued upward growth and technical contributions.
- Good analytical and problemsolving skills with proven ability to think strategically.
- Good understanding of current FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry
- Effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
- Good diplomatic, analytical, and communication skills both verbal and written.
- Good computer skills
- Microsoft Suite proficiency
Qualifications:
- Related BA/BS, required
- 02 years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in Quality Assurance
- Experience in manufacturing operations, laboratory operations and/or QA, preferably in pharma or biotech
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