Quality Assurance Analyst I : 4710145

Artech Information System LLC; Mechanicsburg (Cumberland County); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading IT staffing company in Mechanicsburg is seeking a quality assurance specialist with 3-5 years of experience in the pharmaceutical sector. The candidate will manage quality disposition for materials, conduct audits, and ensure compliance with regulatory requirements. A BS in Science or Pharmacy is required. The ideal candidate should have strong customer service skills and attention to detail, with flexibility for occasional weekends. This role is on-site and offers a dynamic work environment.

Qualifications

• 3-5 years of pharmaceutical experience, ideally in a quality/compliance role.
• Familiarity with warehouse and distribution systems quality.
• Flexible schedule required, including weekends/off shifts.

Responsibilities

• Provide quality disposition on materials and perform product retention exams.
• Interfacing directly with the contractor while working autonomously.
• Conduct routine quality oversight and provide feedback for deviations.

Skills

Pharmaceutical experience

Quality/Compliance/Regulatory/Auditing experience

Customer service relations

Attention to detail

Education

BS in Science/Pharmacy or related field

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

Primary responsibilities

• Providing quality disposition on materials, performing product retention exams, and providing quality reviews of documentation at contract warehouse/distribution center.
• Interfacing directly with the contractor, the Candidate must be highly motivated and be able to work autonomously, requiring little supervision for most assignments.
• They must take initiative to identify and resolve product related issues and procedural deficiencies to improve productivity.
• Attend of routine meetings with Contractor ensure quality system alignment.

Other responsibilities

• Using compliance knowledge base and risk assessment capabilities to provide routine quality oversight of contractor, working directly with the Contractor, Third Party QA and the Supply Chain to assure rapid/appropriate response to quality related matters.
• Provides first response for Quality and Compliance issues noted at the Contract Warehouse, and escalation as appropriate.
• Providing the Contractor guidance regarding interpretation of Regulatory requirements.
• Performs incoming quality checks and batch release activities.
• Verifies transport conditions of incoming materials.
• Releases product for distribution.
• Prepares protocols for specials projects, supervises the protocol execution, and writes reports.
• Provides feedback for deviations and change controls.
• Conducts risk-based quality assessments and makes risk-based decisions for quality issues.
• Assist with resolving issues and initiating process improvements.
• Participates in product launches, site audits/inspections, as needed.
• Performs other duties as assigned.

Skills

This candidate will also need to be flexible in their schedule as well as occasional weekends/off shifts will be required

3-5 years Pharmaceutical experience (including Quality/Compliance/Regulatory/Auditing experience) Experience in warehouse and distribution systems quality role preferred. The ideal candidate will have great customer service relations skills and pay close attention to detail and have overall quality focus.

Supervisory experience is a plus NOT required

Qualifications

Education

Required: BS in Science/Pharmacy/ or related field