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

This function is responsible for supporting the daily manufacturing and facility operations along with project support. This is a Quality role in support of sterile manufacturing operations. Functions include proactive support of change control assessments, documentation reviews and validation review/support. Functions also include reactive support of discrepancy identification and resolution on the floor, Investigation Team Support, TrackWise (assessing product impact), and reporting operational metrics. This function supports and communicates events to shift leadership daily and thresholds when they are outside of the area of responsibility.

Education & Experience:

• Bachelor's degree in a scientific discipline (or equivalent) required


• 5 - 8 years' experience in a Quality Assurance role in the pharmaceutical industry required


• Technical expertise and understanding of cGMP sterile filling manufacturing processes is required


• Strong problem analysis (root cause analysis, risk assessment, and CAPA development) skills are a must


• Experience in document and change control review/ approval is a must


• Familiarity with Validation documentation and processes is a strong plus


• Familiarity with SAP, CMMS, Trackwise is a plus


• Experience in direct interactions with FDA or other regulatory auditors is a plus


• Experience with sterile microsphere or powder manufacturing is a plus

Preferred Knowledge/Skills:

• Strong written and oral communication skills. A thorough understanding of the regulatory process from GLP through commercial manufacturing


• Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues


• Experience in sterile and aseptic product qualification and quality


• Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines


• Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations


• Project management experience including scheduling, tracking and auditing


• Experience in change management and deviation resolution including CAPA systems


• Experience in participating in pharmaceutical technology transfer teams


• Experience in the 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 increase others knowledge of US end European GMP regulations and guidance


• Teacher level knowledge of GMP's


• Demonstrated leadership skills with a high degree of independence and limited oversight


• Demonstrated success with increasing levels of organizational responsibility

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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