Specialist 2, Quality Systems - Training

Antares Pharma, Inc.; San Diego (CA); On-site; USD 78,000 - 109,000; Full time

Benefits offered by this job

Employee Stock Purchase Program

401(k) matching

Tuition reimbursement

Job summary

Join a collaborative team focused on innovative drug delivery and patient impact. This role requires strong communication, independent work, and cross-functional collaboration across Quality, Operations, Engineering, and related departments.

Qualifications

• Minimum two years of college or work experience equivalent.
• Strong computer skills. Fluent with Microsoft Office business software and use of information databases, particularly Word, PowerPoint, and Excel.
• Experience with eQMS software for document management and training, with knowledge in ComplianceWire and/or MasterControl preferred.
• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, directives and guidance.

Responsibilities

• Administer training activities within ComplianceWire and MasterControl Training.
• Execute training assignments and curriculum requests submitted by departments and functional managers.
• Coordinate onboarding and new hire training activities to support timely completion of required training.
• Maintain accurate training records and training data within applicable systems.
• Troubleshooting training-related issues, including access, assignment, curriculum and completion record concerns.
• Coordinate training activities associated with document releases, revisions, and change control activities.
• Provide training records and supporting documentation during audits, inspections, and quality reviews.
• Support document control activities within the Quality Management System, including document routing, review workflows, approvals, releases, revisions and obsolescence activities.

Skills

MS Office

Communication skills

Independent work

Team collaboration

Education

Some college / Associate degree

Tools

ComplianceWire

MasterControl

NetSuite

CAD platforms

Job description

In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number.

We look forward to discovering your talents.

Welcome to an inspired career.

At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team - we rise by lifting others up and believe in the power of working together for the collective win. That's why we need you-to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive.

Join us as a Specialist 2, Quality Systems - Training, and you'll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people's lives.

How you will make an impact

The Specialist 2, Quality Systems - Training shall administer and maintain training, document control, and record management processes within the Quality Management System. In this role, you will maintain training administration activities in ComplianceWire and MasterControl, including training assignments, new hire training coordination, user account administration, and training record maintenance.

You will also be responsible for supporting document control, records management, and ERP system activities, while supporting audit and inspection readiness through the retrieval and organization of training records, controlled documents, and supporting evidence. Additionally, you will support Quality Systems and related processes to help maintain compliant and efficient quality system operations.

In this role, you'll have the opportunity to:

• Administer training activities within ComplianceWire and MasterControl Training.
• Execute training assignments and curriculum requests submitted by departments and functional managers.
• Coordinate onboarding and new hire training activities to support timely completion of required training.
• Maintain accurate training records and training data within applicable systems.
• Troubleshooting training-related issues, including access, assignment, curriculum and completion record concerns.
• Coordinate training activities associated with document releases, revisions, and change control activities.
• Provide training records and supporting documentation during audits, inspections, and quality reviews.
• Support document control activities within the Quality Management System, including document routing, review workflows, approvals, releases, revisions and obsolescence activities.
• Support document-related change control activities and associated workflow tasks.
• Ensure controlled documents are processed in accordance with applicable procedures and regulatory requirements.
• Support retrieval and distribution of controlled documents during audits inspections, and business operations.
• Support records management activities, including storage, retrieval, archival, retention, and disposition activities.
• Maintain records in accordance with company procedures and applicable retention requirements.
• Coordinate records requests to support audits, inspections, investigations and operational needs.
• Collaborate cross-functionally with Quality, Operations, Engineering and other departments to support BOM and item management through ERP systems (e.g., NetSuite), MasterControl and CAD platforms.
• Perform duties in accordance with the Company's Quality Management System and applicable procedures.
• Perform related duties as assigned.

To succeed in this role, you'll need:

• Minimum two years of college or work experience equivalent.
• 2 or more years in supporting training administration and/or learning management systems, with experience in document control, records management, or quality systems within a regulated medical device, pharmaceutical, biotechnology, or related environment.
• An equivalent combination of experience and education may be considered.
• Strong computer skills. Fluent with Microsoft Office business software and use of information databases, particularly Microsoft Word, PowerPoint, and Excel.
• Experience with eQMS software for document management and training, with knowledge in ComplianceWire and/or MasterControl preferred.
• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, directives and guidance.
• Proven ability to communicate effectively; orally and written.
• Ability to manage multiple tasks and projects, using negotiation skills to push tasks to completion.
• Ability to prioritize workload to meet deadlines and to maintain high levels of quality and accuracy.
• Able to work independently, as well as in a cross-functional team environment.
• Customer Service oriented attitude and ability to exercise sound business judgment.

In return, we offer you:

• Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
• Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.
• A collaborative, innovative team that works as one to amplify your impact-on your career, the work you do and patients' lives.

The most likely base pay range for this position is $78,000 - $109,200 per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual's exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.

Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Environmental conditions:

Physical Activities: On a continuous basis, be at a desk for a long period of time; intermittently answer the telephone and type on a computer. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate.

The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.

Travel may be required up to 5% of your time.

Accessibility and Reasonable Accommodations:

Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at [e-mail].

To view all our open positions, please visit our career page. Additionally, our benefit offerings can be found here.