Overview
Performance Tester Jobs in Vienna, VA at 462494978
BioCare, Inc. is comprised of BioCareSD, a leading national specialty distributor of life-saving therapies and LogiCare3PL, a national provider of time and temperature-sensitive pharmaceutical logistics services.
Headquartered in Tempe, Arizona, BioCare, Inc. has been devoted to delivering specialty and therapeutic biological products since 1982. In 2022, the company was named to Inc. 5000 America’s Fastest-Growing Private Companies. And recently, BioCare was recognized by the Financial Times as one of “The Americas’ Fastest Growing Companies 2023.”
BioCare’s DEI mission is to create a workplace that celebrates each team member’s uniqueness and individuality. We believe diversity cultivates strength and growth in our organization. We are committed to a diverse, equitable, and inclusive workplace where employees can freely be their authentic selves. We value our employees and our customers. We are people who care.
For more information about BioCare, Inc., please visit BioCare, Inc. – People who care. (biocare-us.com)
Why you should apply:
Low-cost medical, dental & vision plans
Up to 17 days (136 hours) Paid Time Off accrued during your first 12 months
Up to 40 hours Paid Sick Time accrued annually
401k with 5% employer match
Company paid life and disability insurance
Job summary:
The Sr. Quality Specialist position is responsible for reviewing quality systems and compliance in all areas of operations to include change management oversight, compliance and quality data review, audits and inspections, deviation management, non-conforming product evaluation, qualifications and validations, SOP review and approval, document control, Quality Management System (QMS) administration, and regulatory affairs and serves as a resource to operations on quality issues. The Quality Specialist participates in performance improvement initiatives through data and process analysis.
Primary responsibilities:
Perform site quality assessments as required in compliance with internal policies & procedures and regulatory requirements
Conduct scheduled or random quality inspections
Assist assigned site during customer, supplier, or regulatory body visits
Analyze data utilizing analytical methods and statistical techniques that support and/or measure performance, investigations, sample planning, improvements, corrective actions, preventive actions, implementations, and effectiveness in evaluating internal processes and external performance
Collaborate with cross-functional teams to identify areas for process improvement, risk mitigation, and quality enhancement
Execute validations and qualifications, to include completing documentation requirements
Assist with document control in the Quality Management System
Conduct thorough root cause analyses and implement corrective and preventive actions to address quality issues
Assemble supporting documentation to detail the specifics of potentially non-conforming product events.
Stay current and support compliance of both internal and external regulatory requirements (e.g., FDA/OSHA/NABP/State)
Participate in other Quality processes like Change Control, Quality Risk Assessment & mitigation
Monitor that equipment preventative maintenance is scheduled and performed on time
Monitor monthly temperature monitoring reports to identify trends
Verify workplace safety processes are followed
Possess high motivation, enthusiasm, and dedication to our team and customers.
Deliver quality customer service to all team members, customers, and stakeholders
Perform all assigned duties in keeping with the Enterprise’s core values, policies, and all applicable regulations
Bring any compliance issues to the attention of management
Perform all other duties as assigned by management
Required competencies, knowledge, skills, and abilities:
Proficient computer skills
Proficient in Microsoft Office products
Ability to organize, prioritize, and execute a variable workload and multiple priorities
Ability to maintain confidentiality, high integrity, respect, flexibility, service excellence, and teamwork
Ability to provide high levels of customer service and work effectively with all levels of staff and management
Ability to work independently and in a team environment
Must possess the skills and abilities to successfully perform all assigned duties and responsibilities
Must be able to pass a drug test and background check aligned with state and federal laws and regulations
Required certifications, licenses, education, and experience:
Bachelor’s degree or equivalent work experience.
Four years on-the-job experience in healthcare, pharmaceutical industry, or other regulated industry
Preferred education, competencies, knowledge, skills, and abilities:
STEM background
Good writing, grammatical and editing skills
Good communication and organizational skills
Solid knowledge of lean sigma methodologies required
Critical thinking skills
Ability to investigate issues to root cause and develop safeguards from event(s) occurring again
Commitment to continuous improvement with demonstrated success in leading and influencing team members
Proactively identifying potential issues to prevent their occurrence
Strong attention to detail and accuracy
Experience with MasterControl or other computerized quality management systems is a plus
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 job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Prolonged periods sitting at a desk and working on a computer and/or phone
Visual acuity to accurately read small print in contracts, RFPs, and other documents
Ability to stand, walk, bend, squat, stretch, kneel, reach, grasp, and pinch
Ability to stand or walk in the warehouse environment for prolonged periods of time
Physical ability to occasionally lift, carry, push, and pull up to 40 pounds
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, gender, marital status, national origin, ancestry, disability, genetic information, medical condition, military/veteran status, sexual orientation, gender identity, gender expression, or any other characteristic protected by law.
The above statements are intended to describe the general nature and level of work performed by people assigned to this job. They are not intended to be an exhaustive list of responsibilities, duties and skills required of personnel so classified. Incumbents will follow any other instructions or directions and will perform any other related duties, as assigned by their supervisor.
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Referral program
Tuition reimbursement
Vision insurance
Schedule:
Day shift
Monday to Friday
Work Location: In person
Title: Performance Tester
Company: 462494978
Location: Vienna, VA
