Job Overview
The Quality Assurance Supervisor-Operations will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site, bringing their knowledge and experience in service to patients and pursuing excellence in quality and compliance. The Petersburg site serves as Civica’s new fill-finish facility dedicated to manufacturing and supplying essential generic sterile injectable medications.
The role is essential to ensure 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 the position include establishing and maintaining quality and compliance processes associated with sterile manufacturing and operations from the onset of building and qualifying the facility, leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
Responsibilities also include, but are not limited to, shop floor oversight and the generation, review, and/or approval of policies, procedures, reports, batch records, and other records necessary to support the design, implementation, and maintenance of manufacturing processes that meet or exceed FDA requirements.
Essential Duties and Responsibilities:
- Working across functions, establish and maintain the site’s quality systems related to manufacturing operations to enable reliable supply of quality generic medications to patients.
- Promote a quality mindset and quality excellence approach to all activities.
- Promote a safety mindset and focus on safety for all operational activities.
- Responsible for operational compliance aspects of sterile fill-finish manufacturing of products, including but not limited to aseptic process simulations, terminal sterilization, batch record review, batch disposition, and shop-floor quality.
- Ensure that all aspects of the handling and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
- Establish and maintain Standard Operating Procedures and training consistent with CGMPs for QA shop-floor support.
- Provide leadership, direction, and support to ensure shop floor associates and operators are qualified, achieve a high level of competence, are motivated, and carry out their duties in a safe manner.
- Maintain written procedures and associated records for personnel qualification and training and support the delivery of compliance training sessions.
- Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.
- Support, review and approve equipment qualifications and product and process transfers, including validation, from development and/or other manufacturing sites.
- Establish and maintain Standard Operating Procedures, and training to ensure raw materials, excipients, APIs and components are qualified, and their suppliers are approved in accordance with Civica and GMP requirements.
- Establish and maintain Standard Operating Procedures and training to ensure that all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labeling and drug products are released in accordance with the registered specifications.
- Responsible for Quality shop-floor oversight including real-time batch record review, response to deviations and implementation of corrective actions.
- Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
- Participate in quality risk analysis.
- Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
- Travel is limited but may occasionally be required.
Basic Qualifications and Capabilities:
- Bachelor’s degree in a scientific discipline with a minimum of 5+ years of Quality/CGMP experience in the pharmaceutical industry. Experience in sterile injectable manufacturing and packaging operations is required.
- Strong project management, organization, and execution skills with a proven track record of shop floor manufacturing.
- Quality assurance experience across the product development and commercialization lifecycle.
- Participation and leading activities to support regulatory agency inspections 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.
- Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
- Prior experience in a supervisory role highly desired.
Physical Demands and Work Environment:
The physical demands described here are representative of those required of 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 is frequently required to use hands or fingers to 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.The noise level in the work environment is usually low to moderate.
The company is an Equal Opportunity Employer, a drug-free workplace, and complies with ADA regulations as applicable.
