QC Analyst II at Alkermes, Inc. in Wilmington, OH

GENERAL DESCRIPTION:

The QC Analyst II performs testing of samples submitted to the laboratory in a cGMP compliant manner, as well as according to approved written procedures. The QC Analyst II may be required to write or revise SOPs, analytical procedures, or other analytical documentation at the discretion of quality control supervisory staff.

KEY DUTIES:

Perform testing in accordance with written procedures (i.e. USP/EP/JP grade)
Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices.
Processing of electronic data using procedures that ensure data integrity and security.
Ship samples to contract testing facilities.
Entry of test results from contract laboratories
Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations.
Transcribe results onto analysis reports.
Perform daily standardization and performance verifications on laboratory equipment.
Train new analysts
Comply with site-wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
Identify deviations to written procedures.
Disposal of laboratory waste on an as needed basis.
Identify and report unsafe conditions within the laboratory.
Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation; perform investigative testing.

SKILLS/ABILITIES:

Ability to perform routine analysis, such as wet chemistry and operate basic laboratory equipment.
Understands paperwork review process.
Ability to follow written procedures and exhibit excellent documentation practices.
Basic laboratory knowledge and skills
analytical techniques in wet chemistry/chromatography
Practical experience with various types of laboratory instrumentation
Troubleshooting skills with analytical methodology and instrumentation.
Technical writing skills
Employee must be able to pass a vision exam prior to employment and annually thereafter.

PERSONAL ATTRIBUTES:

Proactively achieves results for the best of the organization.
Willingness to learn new things.
Ability to function in a small company atmosphere.
Ability to cope with a rapidly changing work environment.
Commitment to teamwork.
Commitment to continuous improvement in all areas.
Ability to focus attention to details and ensure high quality work.
Ability to work safely; seek out and encourage safe practices
Responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills

EDUCATION AND EXPERIENCE:

Bachelors Degree in Chemistry with 2+ years of laboratory experience. Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed.

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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.