QA Lead Technical Operations

ECLARO

Harvard (MA)

On-site

USD 90,921 - 96,432

Full time

14 days+

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Benefits offered by this job

401k Retirement Savings Plan

Commuter Check Pretax Benefits

Medical, Dental & Vision Insurance

Job summary

A healthcare solutions provider is looking for a QA Lead Technical Operations in Summit, NJ. This role involves providing quality assurance support and reviewing quality-related documents for compliance. The ideal candidate has a relevant B.S. degree and at least 8 years of experience in quality and regulatory environments. Competitive pay range of $66-$70/hr is offered, along with strong benefits including a 401k plan and health insurance options.

Qualifications

Knowledge of science generally attained through studies resulting in a B.S. in related discipline.
8+ years of experience in GMP, GCP, or GXP focusing on product quality.
Excellent technical writing and oral communication skills are required.

Responsibilities

Provide QA support through quality review and approval of investigations.
Make decisions on non-conformance through understanding of Quality Systems.
Review and approve documentation relating to Quality and Validation.

Skills

Quality Assurance

Regulatory Compliance

Technical Writing

Problem Solving

Data Integrity Principles

Education

B.S. in Biological Science, Engineering, or related discipline

Tools

SAP

LIMS

TrackWise

Veeva Vault

Job description

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This range is provided by ECLARO. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$66.00/hr - $70.00/hr

Job Number: 25-04827

Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a QA Lead Technical Operations for our client in Summit, NJ.

ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:

This position will regularly interact with: Reporting Manager.
Sometimes will interact with departments listed below: Quality Control, Manufacturing Operations, Manufacturing Engineering, Manufacturing Science and Technology (MS&T), Validation, Site Engineering, and Digital Plant.

Pay Rate: $66.00-$70.00/Hour

Responsibilities:

Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.
Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations.
Reviews and approves Quality, Quality Control, Validation and Automation related documents
Review and approves Standard Operating Procedures (SOPs).
Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.
Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal client’s guidelines and requirements.
Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment.
Able to interpret complicated data and make sound decisions, Independently.

Required Qualifications:

Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.
Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality.
Preferred Active member of ASQ or ISPE.
Prior experience of QC equipment Qualification and some project management experience
Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable.
Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper-based batch records desirable.
Excellent Technical writing and oral communication skills are required.
Background in problem solving.
Knowledge of Data integrity principles.
Proven attention to details.
Comfortable working in an FDA regulated environment.
Quality Control Equipment experience.
Technical Writer.
Investigations/Deviation experience.

If hired, you will enjoy the following ECLARO Benefits:

401k Retirement Savings Plan administered by Merrill Lynch
Commuter Check Pretax Commuter Benefits
Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

If interested, you may contact:

Paul Quibuyen

Christian.Quibuyen@eclaro.com

6466952942

Paul Quibuyen | LinkedIn

Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

Seniority level