Quality Control Analyst - BioManufacturing Services
Location:
Marlborough , Massachusetts
Posted:
October 27, 2016
Reference:
2755005
Job Number

2755005

Business

GE Healthcare

Business Segment

Healthcare Life Sciences

About Us

What do you envision for your future? At GE Healthcare, we strive to see life more clearly. Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing healthcare costs, increasing access and improving quality and efficiency around the world.

We are an $18 billion unit of General Electric Company (NYSE: GE), employing more than 52,000 people worldwide and serving healthcare professionals in more than 100 countries. We believe in our strategy - and we'd like you to be a part of it. As a global leader, GE can bring together the best in science, technology, business and people to help solve one of the world's toughest challenges and shape a new age of healthcare.

Something remarkable happens when you bring together people who are committed to making a difference - they do!

At work for a healthier world.

Learn More About Careers at GE

Learn More About GE Healthcare

GE Healthcare Life Sciencesprovides products and services used as tools for biopharmaceutical manufacturing, drug discovery and the latest in cellular technologies, thereby enabling our customers around the world to be more productive, effective and creative. Our motivation is to create better health for more people. Through our five decades of supporting the biopharmaceutical industry and its research partners to become more productive, we are helping to reduce costs, increase access and improve quality in the healthcare system. We use our expertise and know-how in imaginative ways to work with our customers to provide what's needed today and create products and solutions to enable the medical treatments of tomorrow. We add value to our customers by:

* Providing cutting-edge research tools that give deeper insights into cell function to enable disease diagnosis and the development of treatments.

* Enabling manufacturing productivity: we provide solutions for the entire bioprocess workflow (i.e. start-to-finish bioprocessing) helping our customers to develop and manufacture biopharmaceuticals more efficiently.

* Providing high quality support and maintenance services.

We are the home of many famous brands, including Whatman, Amersham, Biacore, WAVE, Applied Precision, Xcellerex and more.

Learn More About GE Healthcare Life Sciences

GEHC - LS

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Posted Position Title

Quality Control Analyst - BioManufacturing Services

Career Level

Experienced

Function

Manufacturing

Function Segment

Manufacturing Quality

Location(s) Where Opening Is Available United States

U.S. State, China or Canada Provinces

Massachusetts

City

Marlborough

Postal Code

01752-7217

Relocation Assistance

No

Role Summary/Purpose

The Quality Control Analyst will perform analytical testing following SOPs. This position will support testing for cGMP biomanufacturing runs, stability studies as well as Assay Qualifications and transfer of methods into QC.

Essential Responsibilities

Key responsibilities/essential functions:

• Perform routine QC testing in accordance with SOPs and cGMP guidelines.

• Write, review and approve QC SOPs, test methods, protocols, and reports to ensure compliance with site, corporate, and regulatory requirements.

• Review QC data; prepare reports and quality documents; support general lab functions.

• Maintain tracking systems, associated databases, and trending systems for QC results

(control charting).

• Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment.

• Comply with EHS regulations & policies

Quality Specific Goals:

1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

2. Complete all planned Quality & Compliance training within the defined deadlines

3. Identify and report any quality or compliance concerns and take immediate corrective action as required

4. Have knowledge and understanding of QC test procedures to ensure products conform to their specifications; participate in OOS/OOT investigations, Deviations and CAPA

5. Ensure the creation of accurate, complete and timely records.

Qualifications/Requirements

1. BA/BS degree in a related scientific discipline (e.g. chemistry, biology)

2. 2 or more years of previous experience in the biotechnology industry in a GMP environment

3. Relevant laboratory experience would include analysis of proteins by SDS-PAGE, Western blots, iCE, ELISA, and HPLC. Familiarity with aseptic technique and tissue culture.

Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.

Desired Characteristics

1. Ability to write clear technical documentation

2. Familiarity with aseptic technique and tissue culture is desirable.

3. Flexibility with scheduling - may include off-shift, weekend, and holiday coverage

4. 5 years of previous experience in the biotechnology industry in a GMP environment
A little about us:
GE imagination at work.

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