GLP GCLP Senior Consultant (Hybrid) Job at Pace Life Sciences, Frederick, MD

Q0xEUzN6dW5rVlpucHpXRkdKVmF2b09OZlE9PQ==
  • Pace Life Sciences
  • Frederick, MD

Job Description

GLP GCLP Senior Consultant (Hybrid) at Pace Life Sciences summary:

The GLP GCLP Senior Consultant at Pace Life Sciences plays a vital role in ensuring regulatory compliance in pharmaceutical and biotechnology sectors. With over 15 years of experience, this position involves conducting audits, developing training programs, and providing strategic advice to clients. The consultant ensures that laboratory operations meet GLP and GCLP standards from early-phase R&D through to commercial product support.

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

Keywords:

GLP, GCLP, pharmaceutical compliance, biotechnology, regulatory affairs, laboratory audits, scientific consulting, clinical trials, drug development, industry standards

Job Tags

Holiday work, Full time, Temporary work, Local area, Monday to Friday,

Similar Jobs

Alstom

EHS Manager Job at Alstom

 ...and smarter mobility worldwide, connecting cities as we reduce carbon and replace cars. Could you be the full-time on-site EHS Manager in Hornell, NY, US were looking for? Your future role Take on a new challenge ensuring and providing a safe and healthy... 

Interim HealthCare of West Des Moines, IA

Occupational Therapy Assistant (COTA) PRN Job at Interim HealthCare of West Des Moines, IA

Home Health Occupational Therapy Assistant (COTA) PRN Home Health assignments throughout Polk, Dallas, and Warren Counties Embark on a new career path where therapy is customized to a patients life and outcomes are optimized. As a Home Health COTA, youll help patients... 

Indian Rivers Behavioral Health

Accounting Assistant - 3369 Job at Indian Rivers Behavioral Health

 ...Job Description Job Description Accounting Assistant Finance Stafford Plaza Full Time; Monday-Thursday: 8:00am-5:30pm; Friday 8:00am-12:00pm - Tuscaloosa, AL - Competencies: # Excellent verbal, interpersonal and written communication skills. # Demonstrated... 

Commodity Fragrances

Performance Marketing Manager Job at Commodity Fragrances

 ...retention, and revenue. The ideal candidate is creative, analytical, and thrives in a collaborative, fast-paced environment. They will work closely with cross-functional teams to ensure that all performance marketing efforts align with our brand values and business... 

Solutions Through Innovative Technologies, Inc

Intern in Aerospace Engineering Job at Solutions Through Innovative Technologies, Inc

 ...consulting firm that has been providing innovative solutions across Engineering, Intelligence, RDT&E, and Professional Services since 2003....  ...STI-TEC is seeking a motivated and detail-oriented Intern in Aerospace Engineering to join our team. This internship provides an...