Proclinical is seeking a Quality Assurance Specialist for a global pharmaceutical company located in New Haven, CT.
The Quality Assurance Specialist executes the site QA activities in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company's business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.
Must be eligible to work in the US.
Job Responsibilities:
- Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
- Provide QA support for risk based verification activities. Review and approval equipment/utilities verification documentation from design to post execution.
- Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
- QA support for implementation of Manufacturing Execution System (MES) and development of batch records.
- Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
- Authoring, review and approval of QA-related procedures.
- Oversee the effective documentation and tracking of quality management system activities including deviations
- and change controls, CAPA, and batch disposition.
- Review and approve Validation protocols as required. (Examples include cleaning, process, method validation).
- Participate in regulatory inspections as required.
- Investigate customer complaints and non-conformance issues.
- Represents Quality Assurance to guide various projects and technical meetings, as needed.
- Responsible for documenting and reporting compliance issues to management.
- Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
Skills and Requirements:
- Min 4 years QA experience in a pharmaceutical manufacturing environment, preferably in a biopharmaceutical environment.
- An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
- Excellent communication & presentation skills are essential.
- Excellent time management organizational skills along with a proven ability to multi-task.
- B.Sc. in science/pharmacy with a minimum of 4 years' experience in cGMP Quality environment; or equivalent combination of education and experience.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at (+1) 857-366-4011 or a.maldonado@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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