?? ??Please only apply if you have reviewed the full description and meet the qualifications
***Must reside in US, Citizen, Green card or Proper Work Authorization***Title:
Manager, QC Microbiology 2nd shift /
M-F ((( 4p-12a
Norwood, MA Target Salary:
$alary, annual bonus & equityThe Role:
2nd shift Quality Control Manager. This position reports into the Director, Quality Control. You will contribute to the development and performance of Quality Control (QC) methods, systems, policies, processes, procedures and controls as they relate to QC testing of raw materials, intermediates, drug substances, and drug products. Additionally, this role will support the environmental and utilities monitoring programs. This individual will provide in laboratory QC Microbiology support to QC Microbiology analysts. Weekend support may be required.Here's What You'll Do:
Here's What You'll Bring to the Table:
- Review executed QC test records for product release, including the investigation and resolution of deviations, OOS and OOT observations.
- Oversee QC testing as required to meet critical timelines.
- Investigate and resolve issues related to assay failures, system deficiencies, deviations, and equipment / assay troubleshooting.
- Responsible for initiation of document reviews, periodic reviews and documentation revisions as needed.
- Participate in continuous improvements of quality systems (procedures and systems) to improve organization effectiveness, quality assurance compliance, and regulatory and other requirements
- Supports resolution of sample management issues to ensure on time delivery of samples per production and testing plans.
- Works with QC management and project team lead to identify and mitigate risks to meeting QC milestones and goals.
- Coordinate training, professional development and growth of the QC staff.
- Establish and maintain a safe laboratory working environment
- Minimum education required: Bachelor's degree in a relevant scientific discipline
- Minimum experience required: BA: 5-8 years in a GMP Microbiology laboratory setting.
- Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs
- Previous supervisory experience is strongly preferred, including testing scheduling and lab project management.
- Strong knowledge of general laboratory operations, method acquisition, qualification.
- Demonstrated proficiency with QC Pharmaceutical Microbiology to include: Microbial Identification, Bacterial Endotoxin Analysis, Sterility, Bioburden, Environmental and Utilities Monitoring.
- Strong written and oral communication skills as well as organizational skills
- Knowledge of industry standards and guidelines, experience supporting compliance audits.
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Knowledge of relevant and current FDA, EU, USP, ICH guidelines and regulations