AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com.

SUMMARY:

We are currently looking for a Quality Control Associate III (Laboratory Operations) to join the AGC Biologics team. This position will perform routine and more complex tasks in support of sample management, control of critical reagents, chain of custody, and stability testing within the Quality Control department. This position may also perform routine laboratory testing, including in-process and release testing of biopharmaceutical products. The ideal candidate will have experience in a GMP laboratory or manufacturing environment, sample and data management, and strong organizational and technical writing skills.

KEY RESPONSIBILIES:

Manage the receipt, inspection, aliquotting, and distribution of GMP test samples from manufacturing to onsite and offsite testing laboratories.
Perform laboratory and data management support tasks, including chain of custody documentation, inventory control, reagent preparation, and maintenance of laboratory instruments.
Oversee contract testing laboratories, review reports, and support investigations for outside testing.
Work closely with Quality Assurance, Manufacturing, Supply Chain, and other internal and external customers to ensure that QC deliverables are completed within agreed upon turnaround times.
Represent QC on cross-functional teams and prepare and present data to internal and external clients.
Author and review procedures, change controls, investigations, and CAPA in support of GMP operations.
Support the QC laboratory during client audits and regulatory inspections. Maintain QC laboratories and facilities in audit and inspection readiness mode.

KNOWLEDGE, SKILLS & ABILITIES:

Ability to understand analytical/technical data.
Clear, concise writing skills.
Good organizational skills and attention to detail.
Ability to interact constructively with co-workers.

EDUCATION/EXPERIENCE:

Education: Minimum BS in Biology, Biochemistry or other scientific discipline
Experience: Minimum of 5+ years hands-on experience with GMP quality systems in support of drug substance manufacturing, testing, inventory management, and/or data integrity.
Experience with the use of LIMS, electronic laboratory notebook (ELN), or other laboratory software systems.

COMPENSATION RANGE:

$78,083 - $93,700 annually

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Apply for this Job

* Required

First Name *

Last Name *

Email *

Phone *

Location (City) *

Resume/CV *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Cover Letter

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

How did you hear about this position? *

If you are being referred to AGC Biologics by a current employee, please enter their name below.

What are your salary expectations? *

Current Mailing Address: *

Address, City and State

Are you willing to relocate? *

If you are able to relocate, do you have a preference between Bothell, WA, Boulder, CO or Longmont, CO?

Have you signed a non-competition or non-solicitation agreement with a former employer? If so, please provide the name of the employer and the date in which the non-competition and/or non-solicitation agreement expires. *

Have you ever been debarred, or are subject to a pending debarment, by the US Food and Drug Administration, or been or are listed by any federal and/or state agencies as excluded, debarred, suspended or otherwise been made ineligible to work in the drug or healthcare industry? *

AGC Biologics may conduct a pre-employment background check which may include criminal, employment, and financial. Is there anything that may prevent you from successfully passing this? Please answer "Yes' or 'No'. If you answered 'Yes', please explain. *

Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply. Will you require sponsorship to legally work in the US now or in the future? *

  I am a US citizen
  I require visa sponsorship
  I require visa transfer sponsorship
  I am a permanent green card holder

LinkedIn Profile URL

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in AGC Biologics ’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Are you Hispanic/Latino?

Please identify your race

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

Autism
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
Blind or low vision
Cancer
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or hard of hearing
Depression or anxiety
Diabetes
Epilepsy
Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
Intellectual disability
Missing limbs or partially missing limbs
Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

Disability Status

¹Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Quality Control Associate III - Laboratory Operations

Apply for this Job

Voluntary Self-Identification

Voluntary Self-Identification of Disability