BIOPHARMA QA ASSOCIATE
HOPEWELL / PENNINGTON, NJ
Responsibilities of this position include but are not limited to review of executed batch records in-process and release tests; and associated supporting documentation from clinical production areas, coordinate record correction activities related to batch release, data review, trending and release data reconciliation against Certificate of Analysis, specification and LIMS.
- Assist in preparation of lot release documentation for accuracy, GMP compliance, and validity.
- Support development of quality Standard Operating Procedures, their revision and perform additional QA related activities as assigned.
- This position will work closely with other QA associates to ensure that all compliance requirements are met in manufacturing, testing, completion of environmental monitoring data reviews, closure of deviations and change controls and availability of supporting documentation to ensure timely disposition of drug substance batches within the required cycle time.
- Support quality team members with facility routine and pre-operational walkthroughs, equipment and room release functions and participate in internal audits as necessary to ensure compliance in GMP areas.
- This quality assurance position will be responsible for collecting metrics related to batch release functions and ensure meeting the required drug substance release cycle time.
- This position will need to work closely with cross-functional groups in resolving any discrepancies observed during the GMP documentation review and report any non-conformances in the executed batch records or reviewed testing so they are addressed appropriately.
- This position will also support investigations associated with manufacturing operations and analytical testing activities and may be rotated on the production floor to provide timely quality support and coaching to production operators during critical operations.
- At minimum, a B.S. degree in Chemistry, Microbiology or other associated biological science.
- Generally, a minimum of 4-6 years of related experience in the pharmaceutical or biologics industry with at least 2 years focused in a quality assurance or regulatory compliance area is required.
- Knowledge of US, EU and cGMP regulations and guidance is required.
- Must have knowledge and general understanding of regulatory requirements pertaining to biopharmaceutical manufacturing.
- Individual must be able to communicate clearly and succinctly, both verbally and in writing.
- Ability to work independently under tight time-lines and make sound judgments while ensuring compliance with regulations and approved procedures.
- Effective interaction with all contacts and the ability to work in a team based environment and interact well with other employees at various levels is expected.
- Personnel must demonstrate flexibility and capability of handling several high priority items simultaneously on an ongoing basis.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Patrick: email@example.com
ALPHA'S REQUIREMENT #17-01097