Position Summary:
The Quality Assurance Operations Shop Floor Specialist is part of the Quality Assurance Operations team at Civica’s Petersburg, Virginia manufacturing facility. The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. This role will function as the most senior member of the Quality Assurance Operations Shop Floor team, interacting with other cross-functional teams to provide oversight of manufacturing operations. The goal of this role is to ensure accuracy, compliance, efficiency, and safety in all aspects of site operations.
Key Responsibilities:
- Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management.
- Develop, review and/or approve temporary and non-routine procedures for event response.
- Observe manufacturing operations and identify departures from proper clean room behaviors, aseptic techniques, and gowning procedures.
- Coordinate and lead area walkthroughs to identify quality issues. Work cross-functionally to create remediations and drive alignment of implementation plans.
- Own actions for departmental programs and propose improvements to programs.
- Communicate and resolve discrepancies independently and escalate as required.
- Author and review procedural documents.
- Provide guidance and training for floor personnel.
- Assess discrepancies for entry into quality system and initiate deviations as applicable.
- May serve as a Quality Assurance subject matter expert for site-wide assessments.
- Lead meetings and represent Quality Assurance function at cross-functional meetings.
- Share data/knowledge within and across partnering teams, all while building & maintaining strong relationships within the quality culture.
- May prioritize and assign tasks for the Quality Assurance Shop Floor team.
- Observe operations occurring on the floor and proactively identify risks and drive improvements.
- Should be familiar with GMP-related management systems including quality documentation, supplies, and equipment.
Basic Qualifications and Capabilities:
- Bachelor's degree or above in a scientific discipline.
- Minimum of 4+ years of experience within a pharmaceutical, biotech, cell therapy, or medical device cGMP-regulated manufacturing environment.
- Experience in sterile pharmaceutical isolator technology, combination products, or medical devices.
- Demonstrated experience delivering training on cGMP regulations, standard operating procedures (SOPs), and quality systems.
- Ability to research, understand, interpret, and apply internal SOP’s, policies, and regulatory guidelines.
- Proficient computer skills with knowledge of digital tools such as MS Office and ability to learn and work with new software applications.
- Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
- Excellent written and verbal skills and ability to present technical data effectively based on the target audience.
- Ability to work in a fast-paced team environment and lead peers through changing priorities.
- Detail-oriented and task-focused with the ability to meet deadlines and support work prioritization.
- Exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
- Demonstrated experience with quality management systems used to compliantly handle records such as change controls, deviations, investigations, as well as corrective and preventative action (CAPA) management.
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 this position requires 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, a drug-free workplace, and complies with ADA regulations as applicable.
