Quality Engineering Specialist 2

Alora Pharmaceuticals; Marietta (GA); In loco; USD 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

Alora Pharmaceuticals, LLC. in Georgia is seeking a Quality Engineering Specialist 2 to independently lead GMP investigations, coordinate CAPA activities, and support QA review of validation and qualification documentation.

You will collect evidence, develop clear narratives, perform risk assessments, and drive timely closure while coaching junior staff and ensuring CFR compliance and quality system requirements.

Competenze

• Bachelor’s degree in a scientific, engineering, pharmacy, or related discipline.
• Typically 3–6 years of GMP experience, including at least 2 years in deviation investigations or CAPA.
• Strong technical writing, facilitation, critical thinking, and cross‑functional coordination.
• Proficiency in Microsoft Office (Word, Excel, Access, Visio).
• Knowledge of FDA CFR basics and quality system records.
• Ability to work with minimal supervision and adapt to changing priorities.

Mansioni

• Lead investigations from problem definition through final report and response.
• Collect records, data, interviews, and process information; resolve inconsistencies.
• Develop impact assessments for batches, products, and patient risk.
• Facilitate root cause sessions and document evidence.
• Propose CAPAs with owners, criteria, dates, and effectiveness checks.
• Coordinate CAPA deadlines and escalation per procedures.
• Analyze deviations and trends; suggest focused follow-up.
• Assist with validation and qualification documentation packages.

Conoscenze

GMP investigations

CAPA/Deviations handling

Root cause analysis

Technical writing

Cross-functional coordination

Data analysis/basic statistics

Formazione

Bachelor's degree in a scientific/engineering/pharmacy or related discipline

Strumenti

Microsoft Office Suite (Word, Excel, Access, Visio)

Descrizione del lavoro

POSITION DETAILS

• Position Title: Quality Engineering Specialist 2
• Function: Quality
• Reports To: Manager, Quality Engineering & Operations Support
• Location: Marietta and/or Alpharetta, GA

POSITION OVERVIEW

The Quality Specialist independently leads routine and moderately complex GMP investigations and coordinates related CAPA activities. Collects reliable evidence, develops clear investigation narratives, and supports timely follow-up while building foundational Quality Assurance skills. Provides assigned QA review of routine validation and qualification documentation, supports change impact assessments and periodic reviews, and coordinates operational quality deliverables.

DUTIES AND RESPONSIBILITIES

• Lead assigned investigations from problem definition through a complete report and response to review comments; coordinating Manufacturing, Packaging, and supporting functions as needed.
• Collect and critically evaluate records, electronic data, interviews, and process or equipment information; reconcile inconsistencies and identify additional evidence needs.
• Prepare initial and final impact assessments addressing affected and potentially related batches, historical products, future operations, patient risk, and data integrity.
• Facilitate structured root cause sessions and evaluate alternative causes; document the evidence supporting the root or most probable cause and any remaining uncertainty.
• Develop proposed CAPAs with functional owners, measurable completion criteria, target dates, and effectiveness checks that address identified causes and contributing factors.
• Coordinate investigation and CAPA due dates, action follow-up, and extension requests in accordance with site procedures; escalating barriers to timely and complete resolution.
• Analyze recurring deviations and assigned complaint investigation data; identify potential trends and recommend focused follow-up.
• Support assigned procedure revisions and process or equipment risk assessments within training and authorization.
• Provide investigation records and technical explanations for audits and inspections; assist in preparing responses and verifying supporting evidence.
• Provide practical coaching to Specialist I personnel on evidence collection, technical writing, and documentation practices.
• Assist with assembling and checking validation and qualification document packages for completeness, correct versions, signatures, traceable attachments, and recorded results under guidance.
• Support review of user requirements, protocols, traceability matrices, and summary reports by identifying missing information and routing technical questions to experienced reviewers.
• Gather equipment history, maintenance or calibration records, deviations, and change records to support periodic qualification and validated status reviews.
• Perform additional duties and responsibilities as assigned.

EXPERIENCE AND QUALIFICATIONS

• Bachelor’s degree in a scientific, engineering, pharmacy, or related discipline; an equivalent combination of relevant education and experience may be considered.
• Typically 3–6 years of relevant GMP experience, including at least 2 years of deviation investigation, CAPA, or equivalent technical investigation experience.
• Demonstrated ability to independently complete routine investigations and apply risk assessment and structured root cause tools.
• Strong technical writing, facilitation, critical thinking, and cross functional coordination skills; proficiency in quality system records and basic data analysis.
• Ability to organize and adapt to organization priority changes and work effectively with minimal supervision / independently with a sense of urgency.
• Solid knowledge of industry and FDA guidance, including CFR basics
• Computer experience required; Proficiency in Microsoft Office (Word, Excel, Access and Visio)
• Proficient in 2 of 4 Quality groups (operations, systems, compliance, engineering)

Preferred Experience / Skills

• Previous experience in performing investigation in manufacturing.
• Quality or Pharmaceutical certifications a plus.

OTHER REQUIREMENTS

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the essential duties of this job the employee is frequently required to stand, walk, and reach with hands and arms. Employee may be required to inspect pharmaceutical equipment which includes crouching to look under equipment and/or contorting to examine difficult to view areas. The employee is regularly required to sit, use the hands and fingers to type via the use of the PC (Personal Computer). Must be able to lift and move up to 20 lbs. Periodic/infrequent travel to sister sites may be required. No Personal Protective equipment required, unless entering in-process production areas.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.