Sr. QA Associate I at Alkermes, Inc. in Wilmington, Ohio

Job Description:

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

Sr. QA Associate I

Position Summary:

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.

Key Duties:

• 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 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


• 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 are preferred


• 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

Education/ Experience:

• 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 preferred


• 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.

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Experience Level:
Associate

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