The Quality Assurance Associate will be responsible for performing functions including daily on the floor activities related to sterile manufacturing operations, on the floor batch record review, executed validation review, discrepancy identification, logbook review, AQL inspection of finished product, SAP transactions, room/utility walkthroughs, shutdown/incident form assessment/review and reconciliation, initiation of hold forms, training program support, and product shipping in a facility that manufactures sterile products in a GMP environment.
Observe manufacturing operations in an aseptic environment.
Communication of identified non-conformances.
Review of manufacturing batch records, executed validation review, Maximo WO’s, and logbooks.
Write or revise SOPs, forms, and deviations.
Follow-up on preventive and corrective actions associated with deviations.
Effective communication with major connections, co-workers and supervisor.
The monitoring of compliance with the requirement of GMP.
Prepare and maintain batch data tables for trend analysis.
Self-starter that takes initiative to perform work with minimal supervision.
Ability to aseptically gown and work in an aseptic environment.
Maintain documentation in accordance with GMP.
Ability to work safely; seek out and encourage safe practices.
Pays attention to detail and ensures GMP compliance is maintained.
Ability to cope with a rapidly changing work environment.
Commitment to teamwork.
Ability to meet timelines as assigned.
Willingness to learn new things.
Commitment to continuous improvement in all areas.
Ability to work hard and contribute to an enjoyable working environment.
Strong written and oral communication skills.
Possesses a good understanding of current quality assurance GMP regulations.
Working knowledge of GMP requirements and associated guidelines.
Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
Displays the appropriate amount of energy and displays the versatility to accommodate changes to ensure all work activities are completed as required.
Ability to increase others knowledge of US end European GMP regulations and guidance.
Requires a Bachelor’s degree in a scientific discipline or equivalent.
1-2 years’ experience in a Quality Assurance role in the pharmaceutical industry.
The successful employee will have the ability to function in a manufacturing environment. The employee should have no health conditions/allergies that would prevent them from doing so or conditions which would prevent them from aseptically gowning.
The employee will be required to participate in an on call schedule for various shift, holiday, or weekend work as needed.
Prolonged periods of sitting or standing.
Occasional periods of repetitive motion.
Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
Steel toe shoes, scrubs, safety glasses, and other PPE equipment must be worn based on job being performed.
Makeup and jewelry will not be permitted for work in classified areas or other areas as necessary
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.