What are the responsibilities and job description for the Quality Assurance Specialist position at Rose International?

Date Posted : 01 / 31 / 2025

Hiring Organization : Rose International

Position Number : 477548

Job Title : Quality Assurance Specialist

Job Location : Berkeley, CA, USA, 94710

Work Model : Onsite

Shift : M-F start 8 : 00am PST

Employment Type : Temporary

Estimated Duration (In months) : 13

Min Hourly Rate ($) : 48.00

Max Hourly Rate ($) : 58.00

Must Have Skills / Attributes : Batch, GMP, Manufacturing, Pharmaceutical, Quality Assurance

Job Description

EDUCATION / EXPERIENCE REQUIREMENTS

Bachelor’s degree in a scientific / technical field
Minimum 7 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations
A minimum of four years of direct experience in Manufacturing and / or Quality in a GMP-regulated industry or an equivalent combination of education and experience

REQUIRED SKILLS

Must have previous experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records and understand the review and approval process

Previous work in Quality Assurance

Proven ability as a team player and leader

Excellent interpersonal skills

Must be able to listen and understand the opinions and perspectives of others while influencing without authority with internal and external customers / stakeholders regarding possible recommendations

Ability to work both independently and team environment

The ability to multitask and support changing priorities

Strong written and oral communication skills

Ability to assess, investigate and resolve deviations

Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities

In depth knowledge of GMP

PREFERRED SKILLS

SAP knowledge (inventory system)

POSITION SUMMARY

Responsible Subject Matter Expert for a specific function to evaluate and approve production department generated documentation (e.g. electronic and paper batch records). Ability to review API (active pharmaceutical ingredients) and Drug substance product to support on-time release of product. Ability to provide technical guidance to production operators and management. Includes identifying and assessing deviations in the batch records using scientific principles, thorough analysis, and compliance minded thought processes which meet cGMP requirements within established timelines.

RESPONSIBILITIES

Reviewing electronic batch records, interacting with QA staff and operations staff

Identifying errors in the batch records and interacting with productions to ensure that the corrections are completed in a timely manner to support the QA release of API and drug substance batches

The week also involves picking up paper batch records from operations (paper records consist of 10% of the reviews)

Assist team member in archiving the paper records

Only those lawfully authorized to work in the designated country associated with the position will be considered.

Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.

Benefits :

For information and details on employment benefits offered with this position, please visit here. Should you have any questions / concerns, please contact our HR Department via our secure website.

California Pay Equity :

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

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