QC Analyst IGeneral Description:
The QC Analyst I will join the chemistry group to perform functions including analytical testing, instrument qualification as required to meet QC cycle times in a facility that manufactures sterile products and tablets in a GMP environment. Responsibilities will also include reviewing, reporting test results and ensuring that all activities within the laboratory are performed in compliance with cGMP, internal written procedures and policies. The analyst will answer questions that arise regarding cGMP and internal requirements of a particular activity or job function. They will also be responsible for assessing quality of products equipment, manufacturing process areas, and utilities.
- Provide technical guidance to the Finish Product group pertaining to analytical testing and instrument troubleshooting.
- Execute analytical testing following compendia (USP, EP, JP), and in-house analytical procedures
- Write protocols and execute method verification/validation/qualification/ transfers
- Write, execute laboratory investigations as needed
- Drafting documents (SOPs, specifications, technical reports)
- Execute, oversee instrument qualification as necessary
- Document data as needed utilizing LIMS, ELN, SAP, SLIM and Oracle
- Troubleshooting of technical procedures, methodology and instrumentation
- Specific understanding of the Oral Solid Dosage process (Drug substance, Drug Product, excipients and other non-chemical raw materials/finished product sampling and testing procedures
- Proficient in QC Release testing procedures.
- Proficient in HPLC, Dissolution, GC, KF, Particle Size and specialized other wet analytical techniques.
- Proficient in LIMS, Empower, Electronic Notebook (ELN) and lean laboratory operations
- Proficient in FDA, ICH, DEA, USP guidelines, cGMP regulations and laboratory safety procedures
- Proficient in laboratory instruments/qualification program as necessary
- Ability to react quickly to changes in project priorities and timelines
- Ability to cope with a rapidly changing work environment.
- Good interpersonal skills and ability to work effectively in a team environment.
- Commitment to continuous improvement in all areas.
- Ability to work safely; seek out and encourage safe practices
- The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills.
- Pays attention to detail and ensures high quality work
- Self-starter that takes initiative to perform work with minimal supervision
- Ability to meet timelines as assigned
- Willingness to learn new things
- Possesses the skills necessary to provide effective training/mentoring
- Displays the appropriate amount of energy and displays the versatility to accommodate changes to ensure all work activities are completed as required
Education and Experience:
- BS degree in Chemistry or related science discipline required
- 1+ year(s) of cGMP laboratory and/or Pharmaceutical Quality experience 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.