Talent.com
Alcami
Compliance Specialist - Audit, GMPAlcami • Wilmington, NC, United States
No longer accepting applications
Compliance Specialist - Audit, GMP

Compliance Specialist - Audit, GMP

Alcami • Wilmington, NC, United States
30+ days ago
Job type
  • Full-time
Job description

Compliance Specialist

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

Job Summary

The Compliance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting audits, supporting inspections, and maintaining quality databases. The Compliance Specialist will perform the role of Lead Inspector for external audits and act as consultant with clients for all levels of regulatory issues.

On-Site Expectations

  • Hybrid position. Must be on-site for client audits. Occasional travel to other sites for audits.
  • 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

  • Host client audits and coordinate with clients.
  • Coordinate with internal team members to complete responses.
  • Write and coordinate audit responses.
  • Perform internal audits as required.
  • Perform quality review and approval of documents, data, protocols, and/or reports.
  • Maintain quality databases and support quality systems.
  • Assist with development of SOPs or other quality documents as needed.
  • Consult with clients on all levels of regulatory issues.
  • Serve as an effective member of the Compliance team and serve as a mentor in area of expertise.
  • Comply with company policies and SOPs.
  • Assist with quality improvement initiatives as needed.
  • Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
  • Other duties as assigned.

Qualifications

  • Bachelor's degree in Chemistry, Biology, or related field with 3+ years of GMP related experience, or Master's degree in related field with 1+ years of related experience, or equivalent educational and work experience.
  • Audit hosting experience preferred.
  • Client facing experience a plus.
  • Supplier management experience in pharmaceutical industry is a plus.

Knowledge, Skills, and Abilities

  • Good knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
  • Good written and oral communication and presentation skills.
  • Good computer skills and knowledge of Microsoft Office products.
  • Ability to be trained.
  • Ability to interact well with employees at all levels.
  • Ability to negotiate.
  • Ability to interface with clients.

Travel Expectations

  • Up to 10% travel for audits.
  • Physical Demands and Work Environment

    The physical demands and work environment characteristics 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. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and listen. The employee is frequently required to stand, walk, and sit. The employee may be occasionally required to climb or balance.

Create a job alert for this search

Compliance Specialist - Audit, GMP • Wilmington, NC, United States

Similar jobs

Work From Home - Product Specialist - $45 per hour

GL1Oak Island, North Carolina
$45.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

Certified Nursing Assistant (CNA)

Saber Healthcare GroupBolivia, NC, United States
Full-time +1

Join Our Team at Autumn Care of Shallotte.This position is located at Autumn Care of Shallotte - 237 Mulberry Street, Shallotte, NC 28470.Join a team where your compassion and dedication as a nursi... Show more

 • Promoted

Remote Building Code Compliance Expert

Micro1Oak Island, North Carolina, US
$50.00–$80.00 hourly
Remote
Full-time

Building Code Compliance Expert.Plan review and blueprint reading.AI data lab for training frontier models and evaluating AI agents.Experts contribute their diverse subject matter knowledge across ... Show more

 • Promoted

Management Training Program

Express Oil Change & Tire EngineersWilmington, NC, United States
Full-time

Express Oil Change & Tire Engineers is the pre-eminent automotive maintenance provider in the nation with over 350 locations across 21 states, leading our industry through excellence, innovation, a... Show more

 • Promoted

Claims Audit Specialist (Remote)

Vaya HealthWilmington, NC, United States
Remote
Full-time

LOCATION :Remote- This is a home based, virtual position that operates within the hours of 8 :30am-5 :00pm on US Eastern Standard time (EST).Vaya Health welcomes applications from NC, SC, GA, TN, V... Show more

 • Promoted

Commissioned Inspector FDA Tobacco Inspection Program

The Bizzell Group LLCWilmington, NC, United States
Full-time

Fda-Commissioned InspectorsThe Bizzell Group is seeking FDA-Commissioned Inspectors to conduct undercover tobacco compliance inspections at retail locations throughout North Carolina.Inspectors wil... Show more

 • Promoted

Senior Quality Manager - Learning Solutions Leader (Remote Eligible, U.S.)

GE VernovaBurgaw, NC, United States
Remote
Full-time

Training Technology SpecialistProvides expertise in analyzing technical learning needs for a business or function then designs and delivers training solutions.Has in-depth knowledge of best practic... Show more

 • Promoted

Analyst, Specialty Underwriting & Portfolio Manager - REIT

Capital oneCurrie, NC, United States
Full-time +1

Analyst, Specialty Underwriting & Portfolio Manager - REIT The Underwriting and Portfolio Management organization is responsible for underwriting new transactions and managing the existing port... Show more

 • Promoted

Junk Removal Specialist

1-800-GOT-JUNK?Wilmington, NC, United States
Full-time

GOT-JUNK? is making the ordinary business of junk removal EXCEPTIONAL!!! Our truck team members earn $15 to $22 with base salary, plus tips and bonuses, YOU CAN EVEN EARN UP TO $22+/ HOUR with ince... Show more

 • Promoted

Border Patrol Agent (BPA) Experienced - New Hire Sign-On and Retention Incentives

U.S. Customs and Border ProtectionKure Beach, NC, US
Full-time

Border Patrol Agent (BPA) – in the Federal Security and Public Safety Sector.You love protecting your community and doing your part to keep our nation safe.But maybe you’re looking for a change of ... Show more

 • Promoted

Flexible remote AI work. Your schedule. Paid weekly, straight to your bank account.

Meridian.aiMyrtle Grove, NC, US
Remote
Full-time

Review and label digital content including text, images, and documents.Every task you complete helps improve how technology interprets information and performs in practical settings.Detail-oriented... Show more

 • Promoted

Medical Billing and Coding - Entry Level Training Program

Dreambound Inc.Myrtle Grove, North Carolina, US
Full-time

Note : This is an educational program, not a job.Successful completion of the program does not guarantee employment but will equip you with valuable skills for the healthcare job market.Looking to ... Show more

 • Promoted

Client Enablement Specialist - Accounting

VantacaWilmington, NC, United States
Full-time

Client Enablement Specialist - AccountingVantaca just achieved unicorn status with a $1.B valuation, so it's safe to say we're past the scrappy startup phase.We're not just building a successful co... Show more

 • Promoted

Physician (MD/DO) - Pulmonology in Bolivia, NC

LocumJobsOnlineBolivia, NC, US
Full-time +1

Doctor of Medicine | Pulmonology.Competitive weekly pay (inquire for details) .LocumJobsOnline is working with CompHealth to find a qualified Pulmonology MD in Bolivia, North Carolina, 28422!.Come ... Show more

 • Promoted

Consumer Opinion Research Participant

GL IncMyrtle Grove, North Carolina
$15.00 hourly
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

Security & Law Enforcement (Master-at-Arms)

US NavyNavassa, NC, US
Full-time

Security & Law Enforcement (Master-at-Arms).This role is open to both entry-level applicants and candidates with prior experience.Those with a background in Law Enforcement, Corrections/Parole, or ... Show more

 • Promoted

Sr Commercial Security Consultant

EveronWilmington, NC, United States
Full-time

Senior Commercial Sales Consultant.At Everon, we truly believe that our people are the difference for our organization, the customers we serve and the communities we protect.When you're a part of ... Show more

 • Promoted

Disclosure Specialist

EVB - Eastern Virginia BanksharesWilmington, NC, United States
Full-time

Disclosure SpecialistThe Disclosure Specialist verifies that mortgage disclosure packages comply with applicable disclosure regulations, as well as investor and agency disclosure requirements.The D... Show more

 • Promoted

Periodic Direct Support Professional (DSP)

AmivieSouthport, NC, United States
Full-time

DSPs play an important part in helping the people we serve live their best lives with meaning and dignity.DSPs are representatives of Amivie and are expected to create and maintain professional, po... Show more

 • Promoted

Insurance Specialist

Bodies in Balance Physical TherapyWilmington, NC, United States
Full-time

Benefits:Competitive salaryHealth insurancePaid time offVision insuranceDental insuranceTraining & developmentInsurance SpecialistJob DescriptionThe primary responsibility of an Insurance Speci... Show more