Quality Assurance Associates I Or II - Open Pool

The Quality Assurance Associate is responsible for the implementation and execution of policies and procedures for the cGMP manufacturing of biologics. Individuals will be working within a cGMP compatible Quality System utilizing Quality Assurance approved SOPs, protocols and / or similar controlled documents.

Candidates must be able to physically enter cleanrooms that require specialized biocontainment protective gowning. Entry into and performing activities in Biosafety Level 2 (BSL) and / or BSL-3 laboratory spaces is expected. In addition, work related to quality assurance and document control in support of GMP manufacturing, testing, and non-GMP production / research may be assigned with the expectations that the employee make use of skills similar to those described above.

Successful candidates must be able to review and audit documentation for compliance to good documentation practices (GDP), data integrity, and to the technical requirements of directive documents (SOPs, protocols, directive documents, etc.). Candidates must be able to perform as part of a team and think critically through instructions, problem solve and make professional judgments about regulatory compliance, quality and continuous improvement paradigms.The different position level(s) require escalating levels of experience in the understanding and application of quality, document control, and regulatory requirements in a GMP and non-GMP environment. Required Job Qualifications Required qualification, rank and salary determined by specific position to be filled.

Minimum Qualifications :

Level I is for individuals with a Bachelors degree in biology, chemistry, or related science, OR a Bachelors degree in an unrelated field plus 0-1 year of professional experience related to the specific assignment or 0-1 year experience in a contract manufacturing organization.

Level II is for individuals with a Bachelors degree in biology, chemistry, or related science and 2 or more years of relevant professional experience, OR a Masters degree with 0-1 professional experience, OR a Bachelors degree in an unrelated field plus 3 or more years of professional experience in a contract manufacturing organization.

Successful candidate must be legally authorized to work in the United States by time of application. Preferred Job Qualifications

• Relative experience commensurate with the specific position to be filled in a GMP quality system or management of cGMP documentation.
• Relative experience commensurate with the specific position to be filled in a contract manufacturing or similar regulated environment.
• Relative experience commensurate with the specific position to be filled in US code of federal regulation fields of GMP, GLP, and / or GXP.
• Experience in BSL-2 or 3 clean room spaces.

Essential Duties Application Details