GMP Document Analyst / Associate Business Analyst

Job Description

Description

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

We empower and support our colleagues

We commit to client success at every turn

We have the courage to do the right thing

We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.

We constantly acquire new skills and learn from our experiences to enhance our collective expertise

GMP Document Analyst Responsibilities:

Primary:

Batch Production Record, logbook, and executed protocol reviews – This requires a good documentation check of the paper record

Form reconciliation – All forms printed at the site have unique identifier and must be turned into the library within 90 days of printing

Use Veeva and work with the library to determine which forms are overdue and help reconciling those

Secondary:

Technical writing for deviations – This would only be utilized if there was availability after primary responsibilities were completed

Support QA area walkthroughs to ensure compliance

Collaborate with clients and Verista colleagues to facilitate completion of wide array of projects and activities

Participate in all phases of system compliance and analytical activities including but not limited to:

Creating test plans and test scripts, executing dry runs, and supporting UAT activities

Creating, reviewing and editing SDLC documents

Supporting vendor audits

Performing activities in relationship to project management and coordination

Ensure system requirements and user processes are properly tested

Various other activities that are performed in support of compliance and various other projects and services provided to Verista client

Perform data analysis and data integrity activities to ensure clients data assets are complete, accurate, secure and available for business usage

Support the implementation and usage of various systems including QMS, Document Management, qualified and non-qualified applications

Requirements:

Bachelor's degree or higher desired

Preferred Knowledge/Experience

Understanding of the Life Sciences industry

Understanding of concepts of a regulated industry

Required Skills

Proficiency using Microsoft Office tools

Required Abilities

Excellent oral and written communication skills with ability to:

Communicate effectively with members of a diverse team

Document test findings and issues in clear, concise terms

Strong problem-solving and critical thinking skills

Ability to work independently and as part of a team, with the ability to transition between the two

Excellent organizational and time management skills

Strong attention to detail

No technical experience is required

Experience with GMP good documentation practices

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$56,980—$67,005 USD

Benefits

Why Choose Verista?

High growth potential and fast-paced organization with a people-focused culture

Competitive pay plus performance-based incentive programs

Company-paid Life, Short-Term, and Long-Term Disability Insurance.

Medical, Dental & Vision insurances

FSA, DCARE, Commuter Benefits

Supplemental Life, Hospital, Critical Illness and Legal Insurance

Health Savings Account

401(k) Retirement Plan (Employer Matching benefit)

Paid Time Off (Rollover Option) and Holidays

As Needed Sick Time

Tuition Reimbursement

Team Social Activities (We have fun!)

Employee Recognition

Employee Referral Program

Paid Parental Leave and Bereavement

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For more information about our company, please visit us at Verista.com

Full-time