Ohio Staffing
Temporary Manufacturing Operations And Quality Systems Role
This role is responsible for supporting the daily activities related to manufacturing operations and quality systems. Key duties include: issuance of GxP documentation, document management system support, support documentation lifecycle (document scanning, verification, retention, and destruction), development of standard operating procedures and other quality related documents, evaluation of executed documentation (logbooks, controlled forms, and other documentation), and support area initiatives and projects. Skills and abilities required include experience in pharmaceutical quality assurance, including the ability to identify and resolve compliance issues, ability to increase others knowledge of US and European GMP regulations and guidance, strong written and oral communication skills, experience in support of quality systems for drug product manufacturing and quality control operations, and working knowledge of US drug product GMP requirements and associated guidelines. Personal attributes include being a team player committed to quality; a motivated self-starter; detail and results oriented; well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and able to embrace change; capable of managing multiple duties and tasks. Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others; good computer skills; good work ethic, dependable, punctual, and flexible; good motivator of personnel; good team player with a can-do attitude; able to get things done on the basis of influence; able to work in a fast-paced environment with multiple issues open simultaneously; highly organized; attention to detail; identifies opportunities to improve and contributes to problem solving. Education: Requires a bachelor's degree in a scientific discipline or equivalent experience. Experience: 0-2 years' experience in a quality assurance role in the pharmaceutical industry. 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 on the basis of race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other legally protected class.
This role is responsible for supporting the daily activities related to manufacturing operations and quality systems. Key duties include: issuance of GxP documentation, document management system support, support documentation lifecycle (document scanning, verification, retention, and destruction), development of standard operating procedures and other quality related documents, evaluation of executed documentation (logbooks, controlled forms, and other documentation), and support area initiatives and projects. Skills and abilities required include experience in pharmaceutical quality assurance, including the ability to identify and resolve compliance issues, ability to increase others knowledge of US and European GMP regulations and guidance, strong written and oral communication skills, experience in support of quality systems for drug product manufacturing and quality control operations, and working knowledge of US drug product GMP requirements and associated guidelines. Personal attributes include being a team player committed to quality; a motivated self-starter; detail and results oriented; well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and able to embrace change; capable of managing multiple duties and tasks. Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others; good computer skills; good work ethic, dependable, punctual, and flexible; good motivator of personnel; good team player with a can-do attitude; able to get things done on the basis of influence; able to work in a fast-paced environment with multiple issues open simultaneously; highly organized; attention to detail; identifies opportunities to improve and contributes to problem solving. Education: Requires a bachelor's degree in a scientific discipline or equivalent experience. Experience: 0-2 years' experience in a quality assurance role in the pharmaceutical industry. 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 on the basis of race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other legally protected class.