6587 - Project Administration Engineer

Description

The company is a life science consulting firm with about 500 experts who work with well-known brands in the life science industry.

The team's work is to help researchers, organizations and companies tackle major healthcare problems through solutions and services that support informed decisions.

The company looks for people who work well in a team and want to help life sciences clients improve lives.

Responsibilities

• Help handle customer complaints, including timely completion of product complaint investigations that follow global and local procedures.
• Review incoming complaints and decide the next steps needed to resolve the issue or issues on time.
• Decide how much analysis a returned sample needs.
• Carry out visual and or functional analysis when needed.
• Verify and close relevant complaints with limited supervision.
• Help manage inventory of complaint samples.
• Help QA staff write GMP documents and complete complaint process metrics, including second person verification (SPV) of complaint data.
• Run project management activities in the life science industry so the project meets client demands.
• Understand lifecycle management for quality applications.

Requirements

• You must be willing to work onsite in Indianapolis, IN.
• You need an associate's degree in engineering, life sciences or a related field.
• You need strong computer skills in all Microsoft Office applications.
• You pay close attention to detail.
• You manage your own work well and solve problems on your own.
• You work well under tight deadlines.
• You communicate well with others and are very resourceful.
• Preferred: knowledge of regulatory requirements such as cGMP, 21 CFR 820, ISO 13485 and Canadian MDR.
• Preferred: knowledge of complaint handling and quality systems, with device or combination product complaint experience preferred.
• Preferred: experience with Veeva QualityDocs.

Conditions

The role is onsite in Indianapolis, IN.

For US roles, the expected salary range is $65,296 to $95,358 USD. The actual pay may fall outside this range depending on factors such as background, training, experience, location, business needs, market demand and competitive practice. The range may change over time.

The company is an equal opportunity employer.

Benefits

• High growth potential in a fast-moving organization with a people-focused culture.
• Competitive pay and performance-based incentive programs.
• Company-paid life, short-term and long-term disability insurance.
• Medical, dental and vision insurance.
• FSA, DCARE and commuter benefits.
• Supplemental life, hospital, critical illness and legal insurance.
• Health savings account.
• 401(k) retirement plan with employer matching.
• Paid time off with a rollover option, plus holidays.
• As-needed sick time.
• Tuition reimbursement.
• Team social activities.
• Employee recognition.
• Employee referral program.
• Paid parental leave and bereavement leave.