Shabas is focused on creating a more diverse, inclusive team at every level and fostering a culture where all employees are engaged to achieve their personal potential and deliver on our customer’s mission. Our scientific and management consulting projects ranging from pharmaceutical R&D to regulatory support for securities market oversight, are at the intersection of government policy, operations, and systems. Working with Shabas is an opportunity to make direct impact on people’s health and government agency missions. Join a team of consulting executives, scientists, policy makers, and technical experts to fulfill your career goals and make a difference.
Shabas is focused on creating a more diverse, inclusive team at every level and fostering a culture where all employees are engaged to achieve their personal potential and deliver on our customer’s mission. Our scientific and management consulting projects ranging from pharmaceutical R&D to regulatory support for securities market oversight, are at the intersection of government policy, operations, and systems. Working with Shabas is an opportunity to make direct impact on people’s health and government agency missions. Join a team of consulting executives, scientists, policy makers, and technical experts to fulfill your career goals and make a difference.
Careers at Shabas
Shabas is focused on creating a more diverse, inclusive team at every level and fostering a culture where all employees are engaged to achieve their personal potential and deliver on our customer’s mission. Our scientific and management consulting projects ranging from pharmaceutical R&D to regulatory support for securities market oversight, are at the intersection of government policy, operations, and systems. Working with Shabas is an opportunity to make direct impact on people’s health and government agency missions. Join a team of consulting executives, scientists, policy makers, and technical experts to fulfill your career goals and make a difference.
Employee Benefits
Our Philosophy: To strive for balance, quality of life and recognition in professional endeavors
- Competitive Salaries
- Employee Assistance Program
- Merit Awards
- Company-provided Laptop
- Cell phone Reimbursement
- Employee Referral Bonus Program
- Flexible Spending Accounts
- Charitable Donations Program
- Training and Tuition Reimbursement
- Team Building and Holiday Events
- Employee Discount Program
- Opportunity for growth
- Health, Vision and Dental Coverage
- Basic Life and AD&D Benefit Coverage
- 401K
Shabas is an equal opportunity employer and supports workforce diversity.
All qualified applicants will receive consideration for employment without regard of race, color, national origin, religion, age, sex, disability, genetic information, sexual orientation, gender identity, pregnancy, child birth or related medical condition, marital status, veteran status or any other characteristic protected by law in terms, conditions and privileges of employment.
Current Opportunities
We encourage innovation and entrepreneurship, and aim to create a learning organization with a workforce that has multi-dimensional experience and skills.
Current Openings
- Location: Virginia, Fairfax
- Creation date: 2023-01-14
- Drive the talent acquisition and on-boarding process for contracts and proposals, which includes recruitment, interviewing, and hiring of qualified job applicants; collaborates with management to understand skills and competencies required for openings.
- Drive HR administration: Employee recruiting, salary negotiation, reference checks, on-boarding, and benefits administration; performance evaluations, employee outreach calls, resolve employee issues and maintain personnel files.
- Drive comprehensive talent management processes and development planning. Analyze organizational data to recommend solutions to improve performance, retention, engagement, and employee experience.
- Design programs in accordance with company-wide human resources policies, procedures and initiatives.
- Provide management and staff with an interpretation of HR policies.
- Advise and support management on setting up international operations including related HR matters and regulatory compliance.
- Drive training needs and identify training solutions to build capability. Facilitate the training of managers and individual contributors on HR programs and policies.
- Provide corporate support such as updating Employee Handbook, organizational policies, and marketing materials, organizational charts, ISO certification support, quarterly newsletter, Sharepoint document management, event planning, oversight of corporate vendors, etc; Provide other related support as may be necessary from time to time.
- Produce or proof-read reports, pre-publication journal articles, compose correspondence, create presentations, format corporate deliverables.
- Establish and maintain relationships with vendors, business partners, government contacts, and media groups.
- Provide other administrative support as necessary, including scheduling team meetings, researching suppliers, making staff travel arrangements, conducting research, and collecting information, supporting journal publication/podcast activities, and any project team specific administrative support as requested.
- Maintain knowledge and awareness of applicable international, federal, state and local human resources laws and regulations as necessary
- Drive assigned special projects to include but not limited to HR initiatives, programs, business and operational improvements and enhancements; social media engagements; and/or external projects with outside agencies, community, and business partners
- Bachelor’s degree in business administration, Human Resources, or a related field from an US accredited college
- Must have US Citizenship
- Minimum 7 years of relevant work experience in Human Resources role such as recruiting,organizational development, employee relations, benefits administration, training, and talent development experience while supporting firm executives and project teams.
- Must have exceptional attention to detail
- Strong organizational and time management skills, and ability to prioritize
- Excellent communication skills in English language (verbal and written) and interpersonal skills to connect with all levels of the organization including employee relations, coaching, communications and presentations
- Strong problem-solving skills and analytical abilities, decision making, negotiating and influencing skills.
- Excellent computer skills; highly proficient in using MS Office 365 suite of tools including PowerPoint, Excel, MS Projects, SharePoint
- Human Resources support experience including recruiting and HR administration is required.
- Partner and collaborate with external staffing agencies, where needed, to fill job openings
- Be able to pass background checks and/or US government security clearance
- Be able to perform duties that are sometimes confidential and\or sensitive, and require the use of judgment, discretion, and tact
- Must be able to work well with international cultures and diverse team members
- Knowledge of local, state, and federal employment and labor laws and regulations.
- Ability to research and understand HR operations in a global environment
- Masters degree in Human Resources or related discipline
- Experience working with pharmaceutical manufacturers, federal contractors in public health space is highly desirable.
- Experience supporting a global organization and recruiting both domestically and internationally is highly desirable
- Familiarity with federal contracting environment is highly desirable
- Experience supporting small business is preferred
- At least two years supervisory/functional management experience
- Active SHRM-CP, SHRM-SCP, PHR, or SPHR certification is preferred.
- Strong business and financial competence used to build business strategy and support organizational decisions.
- Due to the nature of the job, this is an onsite role (Fairfax, VA) but flexibility is available for telework.
- Must be able to work some weekends and extended hours based on as needed and required
- Travel to customer sites including but not limited to Greater DC Metro area may be necessary.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Short Term & Long Term Disability
- Training & Development
- Wellness Resources
Quality Control Associate (GMP)
- Location: Maryland, Perry Point
- Creation date: 2022-11-09
Shabas Solutions LLC (www.shabas.net) is a Fairfax, Virginia-based, small business federal contractor providing management consulting and a range of biomedical scientific/technical services to federal agency customers: Drug Discovery and Development, COVID-19 R&D Vaccine/Therapeutics Development Support, and FDA cGMP Quality Management for Drug Manufacturing, Stockpiling and Distribution (including COVID-19 pandemic response).
Shabas is looking for mutiple full-time associates to serve as Quality Control Associates on a US government project at a FDA-registered, government-owned, medical logistics facility in Maryland.
The Quality Control Associate performs Quality Control inspections and disposition of received and picked items, including pharmaceuticals, vaccines, medical devices, and other healthcare related items. Provides QC Support for warehouse operations and customer projects ensuring compliance to applicable regulatory standards (i.e. DSCSA, cGMPs), local procedures, customer requirements and best practices (GDPs).
Duties and Responsibilities:
- Perform inspection of received materials for damage, compliance to labeled temperature storage requirements (e.g. cold chain), material accuracy, quantity, DSCSA traceability, and other quality/customer specific requirements.
- Perform inspection of picked and packed materials ensuring correct material, labeled temperature storage conditions, accuracy of order, quantity, and other quality/customer specific requirements.
- Responsible for release disposition of received or shipped materials meeting acceptance criteria and quarantining items that do not meet acceptance criteria.
- Initiate Discrepancy Reports and/or Deviation Reports for received items that do not meet acceptance criteria or other Quality issues that occur within the Warehouse. Perform investigations and document resolution. Escalate issues to Senior QA requiring in-depth investigation and dispositioning.
- Identify and quarantine potentially suspect prescription drugs per the DSCSA that may be counterfeit or diverted and notify Senior QA and Logistics Management to investigate.
- Work collaboratively with Quality Assurance, Logistics, Project staff and management to ensure the timely completion of assigned tasks, resolution of issues and Discrepancy investigations.
- Maintain accurate and complete records of activities performed, using the electronic inventory management system or paper-based documentation. Store and archive completed records as applicable or forward to the point of contact for archival storage.
- Provide Quality support and/or guidance for general warehouse operations.
- Provide Quality support for customer projects, such as kitting, as directed by QA Management.
- Perform internal Quality audits of warehouse and applicable operations to verify compliance to applicable regulatory standards, local procedures, customer requirements and best practices, including the accuracy of physical and electronic inventories. Track responses and CAPAs to ensure observations are addressed.
- Support the development or revision of procedures or checklists to support and continually improve processes ensuring quality and compliance to applicable procedural or regulatory requirements and professional workmanship.
- Track metrics relevant to duties such as results of receiving/picking inspections, Discrepancy Reports, DSCSA issues and internal audits.
- Support customer in meeting critical timelines, in which pre-approved overtime work may be required.
- Provide high Quality and professional workmanship when performing tasks.
- Complete and maintain assigned trainings.
- Maintain a clean and safe work environment.
- Travel between organizational facilities required as directed.
Requirements
Required Education and Work Experience:
- High School Diploma/GED
- Minimum seven year’s work experience with High School education (OR five years experience with an Associate degree) working in a warehouse, distribution center or other logistical operations facility OR as a Quality Associate working in the pharmaceutical, food, manufacturing or logistics industry.
- Certification in Six Sigma; Lean Management; or ASQ Quality Inspector, Quality Technician, Quality Auditor; or other Quality related certifications a plus.
Required Knowledge, Skills or Experience:
- A commitment to adhere to the Quality Management System ensuring compliance to applicable regulatory and customer requirements.
- Excellent attention to detail ensuring accuracy of inspecting materials, reviewing documentation and recording information.
- Have a mindset for continual improvement to ensure the highest quality and professional standards are obtained, compliance with applicable procedures or regulatory requirements, while also ensuring a safe work environment and maximizing efficiency.
- Possess strong written, verbal and interpersonal skills. Have ability to communicate effectively and professionally and interact with staff with assorted disabilities.
- Ability to read and interpret documents and follow established procedures.
- Capable of troubleshooting and resolving issues, working with colleagues to determine appropriate corrective and preventive actions.
- Ability to work in a team setting or independently when needed.
- Have good basic math skills.
- Must be comfortable with using computers, web-based applications and Microsoft Word/Excel.
- Understand basic Quality duties such as sampling, inspecting, verifying, releasing, quarantining and rejecting.
- Familiarity with the Drug Supply Chain Security Act (DSCSA), current Good Manufacturing Practices (cGMPs), Good Distribution Practices (GDPs), Good Documentation Practices (GDocP), ISO 9001, or other similar Quality/industry standards a plus.
- Experience in cold chain handling such as the receipt, storage, monitoring, and/or shipping of refrigerated or frozen products a plus.
- Familiarity with Acceptable Quality Level (AQL) sampling and inspection techniques a plus.
- US Citizenship required
- Must be able to pass background check to obtain a Federal Trust clearance.
Benefits
- Competitive compensation package, medical benefits, and retirement contribution
- Company-paid basic life/AD&D, short- and long-term disability insurances, wellness resources, training
- Paid time-off program consisting of vacation, sick, and holidays
