Sign upLog in

Senior Associate Quality Control

Aditi Consulting

Holly Springs, NC

Apply
JOB DETAILS
SALARY
$37–$39 Per Hour
SKILLS
Artificial Intelligence (AI), Automotive Automation, Biotech and Pharmaceutical, Change Control, Consulting, Cross-Functional, Detail Oriented, Documentation Review, GMP (Good Manufacturing Practices), Health Plan Membership, Hospital, Insurance, Laboratory, Laboratory Operations, Leadership, Messaging Technology, Metrics, Onboarding, Purchasing/Procurement, Quality Assurance, Quality Assurance Methodology, Quality Control, Reimbursement, Short Messaging Service (SMS), Speech Technology, Standard Operating Procedures (SOP), Startup, State Laws and Regulations, Support Documentation, Team Lead/Manager, Technical Writing, Telephony, Trend Analysis, Validation Documentation, Writing Skills
LOCATION
Holly Springs, NC
POSTED
30+ days ago
Payrate: $37.00 - $39.00/hr.
 
Summary:
This role requires excellent written communication, grammar, and investigative leadership skills. Candidates should be detail-oriented, proactive, and able to navigate shifting priorities in a fast-paced environment with minimal oversight. They will collaborate with multiple cross-functional teams and should be confident leading meetings and pushing investigations independently through to completion. Experience with Veeva Quality Systems is highly desirable.
 
Responsibilities:
  • Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System.
  • Lead investigation teams and help to collect and report metrics for the systems team.
  • Assist with review of validation documents to support equipment and computerized system onboarding.
  • Author, revise, and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports.
  • Support the startup of a GMP QC laboratory.
  • Support routine activities over the weekends and public holidays as required.
 
Qualifications:
  • At least three years of GMP experience.
  • The ideal candidate will bring at least 3 years of industry experience within a GMP-regulated biotech or pharmaceutical environment
  • Experience as a Deviation Owner with technical writing skills.
  • QC Lab experience.
 
Desired Skills:
  • They must demonstrate strong knowledge of quality systems and QC laboratory operations with a proven ability to write, own, and drive closure of quality records, including deviations, CAPAs, and change controls.
  • Experience with Veeva Quality Systems
 
Pay Transparency: The typical base pay for this role across the U.S. is: $37.00 - $39.00/hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 
 
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
 
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting

privacy@aditiconsulting.com

.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy .
 
#AditiConsulting
# 26 - 02217

About the Company

A

Aditi Consulting

Resume Resources

Free Resume TemplatesFree Resume Builder