QA Specialist I

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. 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/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. This role ensures that all QA activities are in compliance with company SOPs, GMP/GLP standards and client requirements. Ability to work within a dynamic and fast paced environment.

**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 cross-functional 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 problem-solving 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
- 0-2 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