Alkermes
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QA Associate I/II - 3rd Shift
role at
Alkermes .
This role supports daily floor manufacturing activities including batch record review, discrepancy identification, logbook review, status tagging, TrackWise triage, room/utility checklists, and product shipping. The position performs general QA work, applying judgment to resolve problems and provide recommendations within the authority to approve written procedures and other documentation.
Key Duties
Authority to approve written procedures and other documents
Develop Standard Operating Procedures and other quality-related documents
Evaluation of batch manufacturing records and testing records
Follow-up on preventive and corrective actions associated with deviations, lab investigations and environmental excursions
Interact with plant personnel to ensure CGMP compliance
Prepare and maintain batch data tables for trend analysis
Provides backup for other QA and plant site personnel as appropriate
Monitor compliance with GMP requirements
Skills and Abilities
Working knowledge of US Drug Product GMP requirements and associated guidelines
Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
Ability to increase others’ knowledge of US end European GMP regulations and guidance
Strong written and oral communication skills
Experience in administration of quality systems for drug product manufacturing and quality control operations
Personal Attributes
Team player, self-starter, detail-oriented, organized, efficient, good communicator, innovative thinker, problem solver, flexible, can manage multiple duties
Good computer skills
Good work ethic, dependable, punctual, flexible
Good motivator, can influence, work in fast-paced environment, highly organized, attention to detail, identifies opportunities for improvement
Education High school diploma
Experience 2+ years’ experience in a Quality Assurance role in the pharmaceutical industry
Onsite
Seniority level Entry level
Employment type Full-time
Job function Quality Assurance
About Alkermes Alkermes applies its deep neuroscience expertise to develop medicines for complex psychiatric and neurological disorders. A global biopharmaceutical company headquartered in Ireland, Alkermes has a portfolio of proprietary commercial products and a pipeline of clinical candidates. They are recognized as an employer of choice and are an equal opportunity employer.
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QA Associate I/II - 3rd Shift
role at
Alkermes .
This role supports daily floor manufacturing activities including batch record review, discrepancy identification, logbook review, status tagging, TrackWise triage, room/utility checklists, and product shipping. The position performs general QA work, applying judgment to resolve problems and provide recommendations within the authority to approve written procedures and other documentation.
Key Duties
Authority to approve written procedures and other documents
Develop Standard Operating Procedures and other quality-related documents
Evaluation of batch manufacturing records and testing records
Follow-up on preventive and corrective actions associated with deviations, lab investigations and environmental excursions
Interact with plant personnel to ensure CGMP compliance
Prepare and maintain batch data tables for trend analysis
Provides backup for other QA and plant site personnel as appropriate
Monitor compliance with GMP requirements
Skills and Abilities
Working knowledge of US Drug Product GMP requirements and associated guidelines
Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
Ability to increase others’ knowledge of US end European GMP regulations and guidance
Strong written and oral communication skills
Experience in administration of quality systems for drug product manufacturing and quality control operations
Personal Attributes
Team player, self-starter, detail-oriented, organized, efficient, good communicator, innovative thinker, problem solver, flexible, can manage multiple duties
Good computer skills
Good work ethic, dependable, punctual, flexible
Good motivator, can influence, work in fast-paced environment, highly organized, attention to detail, identifies opportunities for improvement
Education High school diploma
Experience 2+ years’ experience in a Quality Assurance role in the pharmaceutical industry
Onsite
Seniority level Entry level
Employment type Full-time
Job function Quality Assurance
About Alkermes Alkermes applies its deep neuroscience expertise to develop medicines for complex psychiatric and neurological disorders. A global biopharmaceutical company headquartered in Ireland, Alkermes has a portfolio of proprietary commercial products and a pipeline of clinical candidates. They are recognized as an employer of choice and are an equal opportunity employer.
#J-18808-Ljbffr