Quality Associate I / II
The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks. Applies job related skills and understanding of policies and standards in completing tasks.
Evaluation of batch manufacturing records and testing records
Initiate and investigate complaints
Authority to approve written procedures and other documents
Develop Standard Operating Procedures and other quality related documents.
Investigate/Approve on deviations and/or preventive and corrective actions associated with deviations, lab investigations and Environmental Excursions
Author/review change control documents for compliance
Interact with plant personnel to insure CGMP compliance.
Provides back up for other QA and plant site personnel as appropriate.
The monitoring of compliance with the requirement of GMP; support regulatory audits
Preferred Skills / 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.
Preferred Personal Attributes:
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 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 team player with a can-do attitude.
Can get things done on the basis of influence.
Can work in a fast-paced environment with multiple issues open simultaneously.
Attention to detail and skilled in critical thinking
Identifies opportunities to improve and contributes to problem solving.
Bachelor’s degree in a scientific discipline or equivalent.
For QA Associate I: minimum of 1 year(s) of Quality Assurance or Manufacturing experience in the pharmaceutical industry
For QA Associate II: minimum of 2 years of Quality Assurance or Manufacturing experience in the pharmaceutical industry
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant 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 class protected by 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.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.