New

PLS Senior Consultant - Frederick, MD

Pace Analytical Services, LLC
life insurance, parental leave, paid holidays, sick time, tuition reimbursement, 401(k)
United States, Maryland, Frederick
Jan 10, 2025
Back PLS Senior Consultant #25-242 Frederick, Maryland, United States Apply Apply for this job now! Apply About Us Pace Life Sciences Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations. Job Description Job Description: We are seeking an experienced GLP and GCLP Consultant to join our dynamic team. The ideal candidate will have a strong background in regulatory compliance within the pharmaceutical, biotechnology, or related industries. As a GLP and GCLP Consultant, you will provide strategic advice and hands-on support to ensure our clients' laboratory operations meet or exceed regulatory requirements. Key Responsibilities: Conduct comprehensive audits of laboratory processes and facilities to ensure compliance with GLP and GCLP regulations. Develop and implement GLP and GCLP training programs for laboratory staff. Advise clients on the design and execution of GLP and GCLP-compliant studies. Prepare and review GLP and GCLP documentation, including standard operating procedures (SOPs) and study protocols. Assist in the preparation for regulatory inspections and audits. Stay up-to-date with changes in GLP and GCLP regulations and industry best practices. Provide ongoing support and guidance to clients to maintain GLP and GCLP compliance. Qualifications: Bachelor's degree in a scientific discipline; advanced degree preferred. Minimum of 15 years of experience in a GLP and GCLP-compliant environment. In-depth knowledge of GLP and GCLP regulations and industry standards. Excellent analytical, problem-solving, and communication skills. Ability to work independently and as part of a team. Strong organizational skills and attention to detail. Additional Information Benefits 80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, parental leave, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance. Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Work Schedule Monday through Friday, 8am to 5 pm