6386 - Technical Specialist / Data Analyst

United States·Foster Citymid

OtherTechnical Specialist

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Quick Summary

Key Responsibilities

Coordinate and manage combination product change control records – Initiate, route, and close change records for product and manufacturing process changes. Initiate, route,

Requirements Summary

3 – 5 years relevant experience in related field and a BS or BA. Experience with medical device development and / or pharmaceutical operations (cGMP environment) required. For US geography,

Technical Tools

OtherTechnical Specialist

Description

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

Responsibilities

~1 min read

→Coordinate and manage combination product change control records –
- →Initiate, route, and close change records for product and manufacturing process changes.
- →Initiate, route, and close change records for the design and development of drug device combination products, including the creation and management of design control documentation.
- →Manage implementation of changes at multiple manufacturing sites and change record closures.
→Coordinate post-market surveillance reports and risk management file updates –
- →Collate surveillance information into yearly reports.
- →Generate annual risk summaries and update risk management files.
→Support complaint investigations and documentation.
→Act as a central hub between cross-functional teams to ensure supply continuity.

Exceptional organizational and time management skills.
Understanding of change controls in a regulated industry.
Experience with project management.
Working knowledge of relevant US, EU, and international medical device and pharmaceutical regulations.
Experience with Veeva Vault.
Ability to work with team members, vendors, suppliers, and contract manufacturers to coordinate changes.

Requirements

~2 min read

3 – 5 years relevant experience in related field and a BS or BA.
Experience with medical device development and / or pharmaceutical operations (cGMP environment) required.

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

$85,000—$145,300 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

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

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