Remote USA
Quality Systems Specialist
- Employment Type: Contractor
- Required Therapeutic Area: None
- Location: Remote USA
For Contract Roles Only:
- Hours per week: 40
- Contract duration: 6 months
- Potential to convert to perm: Yes
- Travel expectations: none
Job Description:
- Manage the full lifecycle of controlled documents, including creation, revision, approvals and archival within the electronic Quality Management System (ZenQMS).
- Ensure that controlled documents, such as SOPs, Policies, etc are accurate, current and compliance with regulatory and internal requirements.
- Collaborate/Coordinate workflows with internal stakeholders to ensure timely completion and alignment of documentation / metadata with procedural requirements.
- Provide day-to-day support to employees on document control and quality system processes.
- Author/support the creation, review, and modification of Standard Operating Procedures (SOPs), Work Instructions (Wis), and supporting documentation.
- Support QA onboarding of all employees/contractors
- Support management of deviation, CAPA, change control within QMS.
Required / Preferred Experience, skills, and qualifications:
- Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmacy) or a related field or equivalent work experience.
- Minimum of 5 years of experience in the biotechnology or pharmaceutical industry
- Understanding of FDA, EMA, and ICH guidelines and regulations. Familiarity with GCP, GMP, and GLP standards.
- Excellent attention to detail, organizational, communication, and problem-solving skills, ability to manage multiple priorities in a dynamic environment. Strong knowledge of Microsoft Office Suite.
- Experience with electronic quality management systems (eQMS) is strongly preferred.