QA Lead Investigator

at  Almac Group

Almac is seeking a QA Lead Investigator for our Durham, NC location. The role of the QA Lead Investigator is integral to the success of the Quality Management System in ensuring that Quality Incidents (QIs), Technical Queries (TQs) and resultant Corrective Actions and Preventative Actions (CAPAs) are initiated, investigated and closed out in a timely fashion to prevent the re-occurrence of incidents and ensure customer satisfaction. The investigation process will involve impact assessment and evaluation of risk.
M-F 8-5

REQUIRED EXPERIENCE / EDUCATION:

HS Diploma (or equivalent)

PREFERRED EDUCATION:

Bachelors Degree with Science background

REQUIRED WORK EXPERIENCE:

Level 1:

• A minimum of six (6) years QA Experience with HS Diploma or three (3) years QA Experience with Bachelor’s Degree
• Experience writing, reviewing and approving investigations
• Experience in CAPA management
• Experience in Root Cause analysis

Level 2:

• Typically, 2-3 years at level 1 before promotion to level 2

REQUIRED KNOWLEDGE:

• Knowledge of Current Good Manufacturing Practices (cGMP)
• Working with Quality Systems

Preferred Knowledge:

• Knowledge of Packaging/Labeling/Storing/Shipping Clinical Supplies
• Familiar with Clinical Trial Process

SKILLS (INC. TYPICAL MENTAL DEMANDS):

• Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:
• Basic mathematical skills
• Microsoft Word, Excel, and general computer skills
• Problem analysis and problem-solving skills
• Communication – verbal and written skills

What can Almac Group offer you?

• Medical, Vision & Dental benefits from the 1st of the month following start date
• 20 days PTO per year, accrued monthly following start date
• 12 holidays per year
• Company paid Long and Short-term disability along with Life Insurance
• 401k company contribution
• Hybrid work available for applicable roles
• Professional development programs/ continuous learning opportunities

Want to see our latest job opportunities? Follow us on
Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 6,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
EEO is the Law
EEO is the Law GINA Supplement
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.

Perform the role of a Lead Investigator for quality related and Almac Group (i.e. IS, Facilities) investigations pertaining to Pennsylvania or North Carolina and other sites as required. Promptly and thoroughly gather information about the incident by speaking directly with personnel involved / Subject Matter Experts in order to gain an understanding of the issue. Use appropriate Root Cause analysis tools (as applicable) to investigate the incident and determine root cause and contributory factors. Document the investigation in the appropriate template and ensure the report is written to a high standard that is acceptable to customers and the regulators.
Manage details in the CAPA management system including raising investigations, logging CAPAs / FUIs. Review and assess reports, CAPA Addendums, and other related forms.
Assist quality management with the following tasks as needed:
Generation of Trending reports
Generating and circulating reports from ORION