Quality Engineer

TALENT Software Services; Phillipsburg (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

TALENT Software Services is seeking a Sr. Quality Assurance Engineer for a 100% onsite role in New Jersey.

The candidate will lead QA programs to ensure regulatory compliance across cGMPs, ICH Q7, and ISO standards, with direct involvement in CAPA, audits, and customer investigations. The position requires 5+ years in QA within pharmaceutical or chemical manufacturing, strong problem solving, and excellent documentation and communication skills.

Qualifications

• 5+ years in QA (not QC) in pharma/chemical manufacturing.
• Experience with GMP deviation investigations and CAPA ownership.
• Proven capability in customer complaint investigations and audits.

Responsibilities

• Lead quality assurance programs to ensure cGMP compliance.
• Manage audit activities (GMP, regulatory, customer, internal).
• Drive CAPA, change control, and validation activities for new or changed processes.

Skills

QA process

CAPA management

Root cause analysis

Audit and inspection

Change control

Validation support

Problem solving

Regulatory compliance

Documentation & reporting

Education

BS in Chemistry/Related

B.Pharm considered

Tools

ISO 9001

GMP/GLP environments

Job description

Role: Sr. Quality Assurance Engineer. 100% onsite. Not a QC role.

Must-have experience

• 5+ years Quality Assurance (QA, not QC)
• GMP deviation and manufacturing investigations ownership, not "assisted with "
• CAPA management including effectiveness checks
• Root cause analysis with named methodology (5 Whys, Fishbone, FMECA)
• Customer complaint investigations frequently missing; direct customer interaction preferred
• Internal audits and ISO 9001
• Change control
• Validation support (process, cleaning, IQ/OQ/PQ)
• Pharmaceutical or chemical manufacturing environment

Also valued

• Hosting customer, certification, and regulatory audits
• Statistical evaluation and process trending (SPC)
• Delivering GMP/GDP training to site personnel
• Supplier quality collaboration

Education

BS in Chemistry, Biology, Biochemistry, Chemical Engineering, or Microbiology preferred. Pharmacy (B.Pharm) and related science degrees will be considered where QA experience is strong.

Industries

Pharmaceutical manufacturing, biotech manufacturing, chemical manufacturing, reagent/life sciences. Medical device as a secondary option.

Screening guidance for suppliers

Resumes should show what the candidate personally investigated and closed number of investigations, types of deviations, CAPAs owned

Batch record review and line clearance alone do not meet the bar

Confirm candidates are able to work 100% onsite before submitting

Job Description: Quality Engineer leads efforts in site quality assurance programs and improvement activities. He/she is responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements. The Senior Quality Engineer is accountable for direct support of several systems, including CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC (supporting the microelectronic, pharmaceutical and reagent product lines as necessary) and Validation.

Quality Engineer acts as the key contact working directly with customers to investigate and resolve complaints and inquiries to ensure expectations are met as well as hosting and managing customer audits, certification/surveillance audits as well as the internal audit program. He/she works collaboratively with other departments in both a leadership and participative manner to integrate the necessary systems.

Work Schedule: 1st Shift (Monday - Friday)

MAJOR JOB DUTIES AND RESPONSIBILITIES

• Leads programs and improvement activities focused on ensuring ongoing effectiveness of the quality management system in accordance with the ISO and GMP requirements
• Leads customer complaint investigations requiring direct interaction with customers as well as raw material suppliers
• Manages and leads audit activities within the site including GMP, regulatory, customer and internal audits; recommends and implements activities to close gaps identified in audits to ensure compliance with applicable requirements
• Performs internal audits at other *** sites and may participate in supplier audits as required
• Responsible for maintaining Corrective and Preventive Action program activities within specific scope of responsibility to identify and implement effective corrective actions
• Ensures facility cGMP compliance is maintained and identifies/implements improvement programs as required
• Provides GMP and GDP training to site personnel
• Leads efforts to drive improvement efforts in global metrics with specific focus on complaints and complaint response time as well as CAPAs
• Works with and provides input to Management of Change process
• Performs statistical evaluations for processes and trending and leads validation activity associated with new products or changes to existing processes and products
• Works collaboratively with supplier quality personnel to identify and resolve quality related issues impacting site performance as well as customer complaint
• Partners collaboratively with external customers, operations leadership, and interacts with all levels of plant operations, R&D, procurement, commercial and quality teams
• Works with all departments to investigate and resolve process and product quality issues
• Performs other duties as assigned with or without accommodation

Skills/Experience

KNOWLEDGE, SKILLS AND ABILITIES

• Excellent writing and presentation skills
• Demonstrated ability to accomplish goals through others
• Demonstrated familiarity with chemical nomenclature and Quality Control testing and methods
• Ability to merge divergent resources into an effective and efficient cross-functional team
• Highly detail oriented with demonstrated strong analytical and problem solving skills
• Ability to navigate in a matrixed environment and work collaboratively in a team environment
• Excellent organization and project management skills
• Ability to interface effectively with people at all levels of the organization, from executive to production line

WORKING CONDITIONS: The work environment is a manufacturing facility, and the appropriate PPE will be required in designated areas. Domestic travel is required on occasion. Required Skills:

QUALIFICATIONS

• Minimum of five (5) years of experience in quality engineering or a related role required
• Experience working within pharmaceutical, biotechnology and/or chemical environments required
• Experience working within cGMP/ISO 9000 regulated environments required:

Degree Requirement: Bachelors Degree in chemistry or a related field required