Location: Cincinnati, Ohio
Type: Contract
Job #36575

The QC Analyst I/II will join chemistry group to perform analytical testing, instrument qualification as required to meet QC cycle times following cGMP. 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 II will answer questions that arise regarding cGMP and internal requirements of a particular activity or job function.

Key Duties:

Execute analytical testing following in-house analytical procedures and compendia (USP, EP, JP).
Execute method verification/validation/qualification/ transfers
Execute laboratory investigations as needed
Drafting documents (SOPs, specifications, technical reports)
Execute, oversee instrument qualification as necessary
Review data as needed utilizing LIMS, ELN, SAP, SLIM and Oracle
Troubleshooting of technical procedures, methodology and instrumentation

Skills/Abilities:

Specific understanding of the finished product sampling and testing procedures in a cGMP environment.
Proficient in QC Release (Oral Solid Dosage, Polymers and/or Proteins) testing procedures.
Proficient in HPLC, Dissolution, GC, KF, DSC, Particle Size, In-Vitro techniques and specialized in other wet analytical techniques.
Proficient in LIMS, Trackwise, Empower and lean laboratory operations
Proficient in FDA, ICH, DEA, USP guidelines, cGMP regulations and laboratory safety procedures
Ability to react quickly to changes in project priorities and timelines

Personal Attributes:

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.

Education and Experience:

Minimum BS degree in Chemistry or related scientific field
Approximately 3 years’ experience in pharmaceutical quality control laboratory if preferred but applicable lab experence is acceptable

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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