Sr. QA Associate I 5/6/2020
JOB DESCRIPTIONAPPLY Sr. QA Associate I
The position will perform QA work responsibilities in support of manufacturing and facility operations, including quality systems and projects. Functions include proactive support of change control assessments, documentation reviews, discrepancy identification and resolution on the floor.
* Ensures compliance to internal procedures, policies, and standards, as well as all relevant State, Federal and International regulations during oversight of the operations.
* Approve complaints, change controls, deviations, CAPA, batch records, validation reports and other controlled documents
* Identifies compliance risks and develops sound rationale as basis for audit observations.
* Supports the coordination activities and assists with interactions during regulatory agency inspections
* Perform internal audits, risk assessments and author annual product reviews.
* Participates in the review and revision of Compliance-related controlled documents.
Preferred Skills / Abilities:
* Extensive knowledge of US Drug Product cGMP 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 and European GMP regulations and guidance.
* Experience in quality systems for drug product manufacturing and quality control operations.
* Experience in Pharmaceutical aseptic operations
* Project management experience including scheduling, tracking and auditing.
* Technical expertise and understanding of cGMP sterile filling manufacturing processes
* Strong problem analysis (root cause analysis, risk assessment, and CAPA development) skills
* Experience in document and change control review/ approval and auditing
* Familiarity with Validation documentation, qualification of facilities, utilities, equipment and processes.
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 work ethic, dependable, punctual, and flexible.
* Good motivator of personnel. Can get things done on the basis of influence.
* Can work in a fast-paced environment with multiple issues.
* Identifies opportunities to improve and contributes to problem solving.
* Familiarity with SAP, CMMS, Trackwise, is a plus
* Ability to increase others knowledge of US end European GMP regulations and guidance.
* Strong written and oral communication skills.
* Bachelor s degree in a scientific discipline or equivalent required
* Minimum of 5-8 years experience in a Quality Assurance role in the pharmaceutical industry required
* CQA preferred
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.