Deviation Investigator

Lancesoft

Greenville, NC

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JOB DETAILS

SALARY

$40

LOCATION

Greenville, NC

POSTED

27 days ago

Duration: 9 Months
Pay range: $40.00 - $50.00 Hourly
Shift: 1st shift, Mon- Friday
Location: Onsite at Greenville, NC

Job Description: How will you make an impact?
A leading pharmaceutical organization is seeking a Deviation Specialist to support its quality and compliance operations within a high-volume sterile manufacturing facility. This role focuses on conducting thorough investigations, driving root cause analysis, and contributing to continuous improvement initiatives in a regulated environment. This role ensures that all deviations are managed in compliance with company policies and industry regulations, and that corrective and preventive actions (CAPAs) are implemented effectively. The ideal candidate will be a skilled technical writer with strong communication and problem-solving abilities, and a comfort level in navigating complex production environments.
Key Responsibilities:
1. Deviation Management:
o Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines.
o Conduct thorough investigations to determine the root cause of deviations.
o Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs).
2. Documentation and Reporting:
o Maintain accurate and detailed records of all deviations, investigations, and CAPAs.
o Prepare and present deviation reports to management and regulatory authorities as required.
o Ensure documentation is completed in accordance with Good Documentation Practices (GDP).
3. Compliance and Quality Assurance:
o Ensure all deviations are managed in compliance with company policies, industry standards, and regulatory requirements.
o Participate in internal and external audits and inspections, providing necessary documentation and information related to deviations.
4. Continuous Improvement:
o Analyze deviation trends and provide insights for continuous improvement initiatives.
o Participate in training programs to enhance knowledge and skills related to deviation management and quality assurance.

Qualifications:
•Regulated Industry, cGMP environment experience, deviation management, or a e.G., Pharmaceuticals, Manufacturing, Engineering, Medical, Law Enforcement, etc.].
•Strong Attention to details, technical writing, Analytical and problem-solving skills.
•Knowledge of regulatory requirements and standards.
•Intermediate to Advanced skills in Microsoft Suite (Word, Excel, PowerPoint)
•Excellent communication and interpersonal skills.

Preferred Qualifications:
•Associate or bachelor’s degree in a relevant field such as Life Sciences, Engineering, Medial, or Quality Management.
•Preferred Experience: Biologics, Aseptic, Filling Isolators, Six Sigma Certification, Electronic documentation systems.
•Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

Working Conditions:
•This job operates in a professional office environment as well as the Production, Laboratory, and Warehouse environment in a pharmaceutical facility.
•While performing the duties of this role, the employee is required to walk, sit, and use hands to handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk, and hear. The work is typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as temperature extremes, loud noise, strong drafts, or bright lights.

Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:

Four options of medical Insurance
Dental and Vision Insurance
401k Contributions
Critical Illness Insurance
Voluntary Permanent Life Insurance
Accident Insurance
Other Employee Perks

About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/