Quality Assurance Specialist jobs in Petersburg, VA

Benefits:

• 401(k)
• Competitive salary
• Dental insurance
• Health insurance
• Opportunity for advancement
• Paid time off

Job Description

The QA Operations Specialist will join the organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as the companies new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

The role is essential to assure the Petersburg site’s manufacturing and operations activities comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines.

Responsibilities of this position include, but are not limited to, Quality Operations review and approval of materials, bill of materials, batch records and GMP documentation to support the design, implementation, and maintenance of manufacturing processes that meets or exceed FDA requirements.

This is an exclusive listing.

Essential Duties and Responsibilities:

• Support operational compliance aspects of sterile fill-finish manufacturing of products including but not limited to material, bill of material and executed batch record review and approval.
• Partner with operations to develop manufacturing batch records to be compliant with regulatory and company requirements.
• Working cross-functionally to determine defect criticality, inspection methods, and training plans for both QA Operations and Manufacturing employees.
• Provide cross-functional support to MSAT and Operations in establishing process limits for manufacturing processes such as filling and packaging.
• Act as a resource for colleagues.
• Lead or participate in Quality Risk Management Processes as needed.
• Promote a safety and quality-first mindset in daily job functions.
• Consistently represent the Quality Unit as a proactive and GxP-compliant team player when working with Operations in daily job duties.
• Ensure that all aspects of the handling, and manufacturing of pharmaceutical products at the site comply with company and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
• Support material receipt, quality control, chain of custody, disposition, and release of materials within the Enterprise Resource Planning system.
• Maintain current knowledge of FDA and company requirements to keep pace with evolving requirements for manufacturing.
• Support, lead, or approve documents, change controls, investigations and CAPAs to support the Quality Management System.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
• Proactively be a team lead for department objectives with a minimal amount of supervision.

o Includes complex project management that may overlap with other functional areas.

• Support site objectives with a minimal amount of supervision.

o Includes simple project management that may involve other functional areas.

Basic Qualifications and Capabilities:

• Bachelor’s degree with 4 years of experience in a QA role in a cGMP production environment.
• Associate degree with 6 years of experience in a QA role in a cGMP production environment may be considered.
• Ability to apply technical expertise to solve problems and issues.
• Participating in and leading activities that support regulatory agency inspections is required.
• Project management, organization, and execution skills are required.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills, and share knowledge with others.

Preferred Qualifications:

• Manufacturing Batch Record Design experience is highly desirable.
• Technical expertise in sterile pharmaceutical isolator technology, combination products and medical devices is highly desirable.
• Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.

Shift: Day Shift. Monday through Friday.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.