Entry Level QC Reviewer - Vaccines

This is a fully remote role supporting our BioAnalytical lab in Richmond, VA. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including a drug screening.

Schedule

Monday - Friday from 8AM-5PM (First Shift / Days).

Environmental Conditions

• Work is performed in an office and/or a clinical laboratory environment with exposure to electrical office equipment.
• Occasional drives to site locations and domestic travel.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Rare exposure to skin and lung irritants, radiation, toxic materials, and hazardous waste.
• Personal protective equipment required (e.g., protective eyewear, garments, gloves).
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Responsibilities

• Perform lab work in accordance with client protocols, methods, and requirements.
• Prepare study protocols, project status reports, final study reports, and other project-related technical documentation.
• Design experimental studies and participate in technical troubleshooting.
• Review, interpret, and analyze data for technical quality and compliance to protocols, methods, and SOPs.
• Review laboratory investigations and deviations.
• Organize, schedule, and supervise laboratory resources for group project activities; update project status.
• Respond to client questions and needs; coordinate client communication and record meeting minutes.
• Assist group leaders in their responsibilities.
• Assist in preparation and implementation of PPD/client SOPs and company operational policies.
• Ensure adherence to SOPs, safety standards, and company policies.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 years). In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered sufficient.

Skills

• Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
• Knowledge of applicable regulatory authority, compendia, and ICH guidelines.
• Excellent manual dexterity skills.
• Good written and oral communication skills.
• Time management and project management skills.
• Proven problem-solving and troubleshooting abilities.
• Ability to cross-train on sample preparation techniques with another laboratory group.
• Ability to work in a collaborative team environment.

Physical Requirements

• Ability to work in an upright and/or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
• Occasional mobility needed.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
• Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
• Ability to perform under stress and multi-task.
• Regular and consistent attendance.

Pay

The hourly pay range estimated for this position based in Virginia is $21.00–$21.63. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• A choice of national medical, dental, and vision plans, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).
• Accident, life, short-term, and long-term disability insurance in accordance with company policy.
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.