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Deviation Investigator
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What they do
A Technical Writer writes product instructions, user manuals or other material that helps to explain complex information or procedures. Writes help information available to customers online, or clear explanations of company policies. Supports internal communication among different technical, engineering and scientific specialists working on a project or product. Creates product documentation, and provides input for improving product design.
$74,955 / year median in the U.S.
-11% projected decline
Job Description
Job Title:
Deviation Investigator Job Description The Deviation Investigator supports people, equipment, and processes in operational areas to ensure business objectives and regulatory requirements are consistently met. This role collaborates closely with cross-functional stakeholders, particularly production and quality assurance, to investigate deviations, implement quick containment actions, and drive effective root cause analysis. The position offers hands-on exposure to pharmaceutical manufacturing investigations and provides an excellent opportunity to develop expertise in a highly regulated, global environment. Responsibilities Work directly with production and quality assurance teams to investigate deviations, implement quick containment actions, and perform thorough root cause analyses. Ensure processes and activities comply with internal standards, procedures, and applicable regulatory requirements. Identify process needs and improvement opportunities for routine to minimally complex issues, and support implementation of corrective and preventive actions. Perform process confirmations to verify adherence to procedures and to sustain process improvements over time. Review batch production records (BPRs) as necessary to support investigations and ensure documentation accuracy and completeness. Apply systematic problem-solving methods to analyze issues, document findings, and recommend effective solutions. Support CAPA (Corrective and Preventive Action) activities related to deviations and process improvements. Collaborate with cross-functional teams in production, quality, and other support functions to ensure timely resolution of deviations. Follow all safety and environmental requirements while performing duties in office and production areas. Maintain clear, accurate, and compliant written documentation related to investigations and process changes. Perform other related duties as assigned to support operational and quality objectives. Essential Skills Associate's degree in technology, engineering, or a related technical field from an accredited institution, or a High School Diploma or equivalent with a minimum of two (2) years of manufacturing experience, preferably in a pharmaceutical manufacturing environment. Minimum of one (1) year of manufacturing experience in a pharmaceutical manufacturing environment preferred. Experience with deviation investigation or quality assurance activities. Strong systematic problem-solving skills, including the ability to perform structured root cause analysis. Experience with CAPA (Corrective and Preventive Action) processes and methodologies. Pharmaceutical manufacturing experience, including familiarity with regulated production environments. Excellent written communication skills, with the ability to produce clear, concise, and compliant technical documentation. Knowledge of Good Manufacturing Practices (GMP) preferred. Familiarity with quality or manufacturing systems and tools preferred. Prior manufacturing experience, ideally in a highly regulated environment. Additional Skills & Qualifications A background in engineering, technology, or a related technical field is strongly preferred. Pharmaceutical manufacturing experience is a plus and will support success in deviation investigations and process improvements. Exposure to environmental monitoring, aseptic operations, and compliance activities is beneficial. Experience in technical writing, particularly for investigations, reports, and CAPA documentation, is highly valued. Ability to collaborate effectively in cross-functional teams spanning office and production environments. Strong attention to detail and a commitment to maintaining high quality and compliance standards. Motivation to grow within a global pharmaceutical organization and gain deeper expertise in investigations and quality systems. Work Environment This is an on-site role with a standard schedule of Monday through Friday, typically from 8:00 a.m. to 5:00 p.m. The position operates in a cross-functional setting, with time spent in an open office environment that may include frequent distractions, as well as on the production floor in partnership with manufacturing teams. The role involves working within a regulated pharmaceutical manufacturing environment that follows strict safety, environmental, and GMP requirements. The Deviation Investigator will engage with modern quality and manufacturing systems and collaborate closely with multiple departments, gaining exposure to both office-based analytical work and hands-on production support in a dynamic, growth-oriented organization. Job Type & Location This is a Contract position based out of Clayton, NC. Pay and Benefits The pay range for this position is $31.24 - $31.24/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Clayton,NC.
San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.Benefits
- Paid Time Off (PTO)
- Sick Leave
- 401(k) Plans
- Other Retirement and Savings