Alkermes
QA Associate II/III - 3rd shift
Alkermes, Wilmington, Ohio, United States, 45177
Job Description
This position is located in Wilmington, OH.
Position Summary
Alkermes is seeking an experienced individual responsible for supporting the daily manufacturing and facility operations, along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support. Functions also include reactive support of discrepancy identification and resolution on the floor, Investigation Team Support, TrackWise (assessing product impact), and reporting operational metrics. This function supports and communicates events to shift leadership on a daily basis.
Qualifications:
•Bachelor's degree in a scientific discipline strongly desired.
•Minimum 2-5 years related experience in a Quality Assurance role in the pharmaceutical industry.
Technical Knowledge/Skills Needed:
•Strong written and oral communication skills.
•Basic introduction / understanding of the regulatory process from development through commercial manufacturing.
•Pharmaceutical Quality Assurance experience, including the ability to identify and resolve compliance issues.
•Familiarization with oral solid dose manufacturing qualification and quality.
•Experience in change management and investigation resolution including Deviation and CAPA systems. Experience with Lab Investigation and Complaint systems is a plus.
•Basic knowledge of US Drug Product GMP requirements and associated guidelines. Knowledge of European Drug Product requirements and guidelines is a plus.
•Demonstrated experience in implementation and administration of quality systems for drug product manufacturing. Experience in drug product development and quality control operations is a plus.
•Project management experience including scheduling, tracking and auditing is desired.
•Active participation on pharmaceutical technology transfer teams and CMC team as required
•Experience with the qualification of facilities, utilities, equipment and processes.
Personal Attributes Needed:
Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage and prioritize multiple duties and tasks. Ability to increase others' knowledge of US end European GMP regulations and guidance. Teacher level knowledge of GMPs. Developing leadership skills with a moderate to high degree of independence and oversight. Demonstrated success with increasing levels of organizational responsibility.
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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.
This position is located in Wilmington, OH.
Position Summary
Alkermes is seeking an experienced individual responsible for supporting the daily manufacturing and facility operations, along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support. Functions also include reactive support of discrepancy identification and resolution on the floor, Investigation Team Support, TrackWise (assessing product impact), and reporting operational metrics. This function supports and communicates events to shift leadership on a daily basis.
Qualifications:
•Bachelor's degree in a scientific discipline strongly desired.
•Minimum 2-5 years related experience in a Quality Assurance role in the pharmaceutical industry.
Technical Knowledge/Skills Needed:
•Strong written and oral communication skills.
•Basic introduction / understanding of the regulatory process from development through commercial manufacturing.
•Pharmaceutical Quality Assurance experience, including the ability to identify and resolve compliance issues.
•Familiarization with oral solid dose manufacturing qualification and quality.
•Experience in change management and investigation resolution including Deviation and CAPA systems. Experience with Lab Investigation and Complaint systems is a plus.
•Basic knowledge of US Drug Product GMP requirements and associated guidelines. Knowledge of European Drug Product requirements and guidelines is a plus.
•Demonstrated experience in implementation and administration of quality systems for drug product manufacturing. Experience in drug product development and quality control operations is a plus.
•Project management experience including scheduling, tracking and auditing is desired.
•Active participation on pharmaceutical technology transfer teams and CMC team as required
•Experience with the qualification of facilities, utilities, equipment and processes.
Personal Attributes Needed:
Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage and prioritize multiple duties and tasks. Ability to increase others' knowledge of US end European GMP regulations and guidance. Teacher level knowledge of GMPs. Developing leadership skills with a moderate to high degree of independence and oversight. Demonstrated success with increasing levels of organizational responsibility.
#LI-RS1
#LI-Onsite
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.