Quality Systems Specialist
What’s the opportunity?
The Quality Systems Specialist ensures compliance with Quality System requirements.
What will I be doing?
The Quality Systems Specialist works collaboratively with personnel from other functional areas, such as, Packaging, Compliance, Procurement, Business Development, and Sales, in providing leadership for the development, maintenance, and continuous improvement of Quality System program and processes throughout the company. This includes, but is not limited to, Management Review, Change Control, Internal Audits, Training, Document Control, Record Retention, Product and Customer Complaints Handling, CAPA Program, which includes the Deviation, Corrective Action and Preventive Action (CAPA).
Responsibilities may include the following and other duties may be assigned:
- Leads the development, maintenance and continuous improvement of quality programs, processes and procedures.
- Responsible for interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Ensures Quality System policies, procedures and performance conform to regulatory requirements, standards, and guidelines.
- Owns and leads quality system processes performance and improvements; including, but not limited to, Management Review, Change Control, Internal Audits, Training, Document Control, Record Retention, Product and Customer Complaints Handling, Deviation reporting and investigations, Corrective Action and Preventive Action (CAPA)
- Works directly with internal and external suppliers and customers to ensure quality system requirements are met.
- Performs internal audits and inspections, including writing of audit report and presenting to upper management. Responsible for adherence to audit timelines and reporting.
- Assists with external audits of suppliers as needed.
- Responsible for managing customer and regulatory audits and inspections, including audit/inspection response and tracking.
- Leads recall related activities for customer communication, product returns and FDA reporting.
- Prepares and presents quality system performance reports to senior management.
What skills do I need?
- Minimum 3-5 years in pharmaceutical operations required. Bachelor’s degree preferred. Internal auditing experience is a plus.
- Standard office equipment, computers, etc.
- Gowning for production full-body suit, goggles, cap, booties, gloves, and respirator.
- Strong working knowledge of FDA GMP regulations and quality system regulations/requirements
- Knowledge of manufacturing processes.
- Required working knowledge of basic Microsoft Office applications. Some knowledge of data analysis software and reporting (e.g., Excel, etc.).
- 10-15% travel for audits or training purposes.
In addition, we would also like you to have:
- Good communication skills at all levels, both written and verbal; both individually and in a group setting.
- Strong skills in analytical thinking and problem solving.
- Ability to perform multiple tasks and ability to effectively manage conflict.
- Ability to lead and work in teams to obtain results.
- Proactively identify issues and take action.
- Good decision making skills. Ability to make decisions with limited information.
- Effectively manage change and comfortable changing direction and acting without complete information.
- Good organizational and prioritization skills.
- May be required to work longer than the typical 8-hour work day.
- Sedentary position that may requires pro-longed long periods of desk work.
- Requires light physical duties in keeping work areas clean and organized. Regularly required to walk the production and warehouse areas.
- Maintain a strong attendance record.
- Must be able to pass screening, drug test and background check. Adhere to company’s drug-free workplace policies.
- Must be enthusiastic, self-disciplined and punctual.
- Self-discipline and a desire to achieve results.
- Must be flexible with a desire to achieve high quality results.
- Must be detail-oriented.
- This is a full-time direct hire position working with a great company in the Camarillo area. In addition to playing a key role in the success of the company, you will receive:
- Competitive salary range of $58k to $68k plus 15% bonus DOE
- 401k with employer match
- Medical, Dental and Vision
- Vacation, Holiday and Sick time paid
Job Reference #: 44DN
Location: Camarillo, CA