QC Manager, 2nd Shift
Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 20886-AB1
Compensation : 120000.00 - 135000.00 USD/YEAR
Start Date : 02/04/2022
Hours : Full Time
Required Years of Experience : 7
Required Education : BS Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for a Quality Control Manager for 2nd shift to support clinical and commercial production by ensuring analytical testing for process check points, stability, and release assays conform to quality standards for all products manufactured.
- Oversee QC and laboratory personnel for safe and efficient verification, approval, release/disposition of company products and materials. Simultaneously prioritize, schedule, and manage multiple projects.
- Hiring, developing, training, and evaluating QC personnel based on business needs
- Ensure compliance with applicable cGMP and GTP regulations and company and client methodologies.
- Assure alignment and efficient continuity in laboratory practices between sites
- Approve investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records
- Ensure completion of all client QC requirements related to GMP cellular products
- Oversee QC role in material dispositions via deviation reporting system and Certificates of Analysis
- Monitor effectiveness of quality systems, change control activities for internal and client audit findings.
- Evaluate and investigate customer complaints and deviations; coordinate corrective and preventive actions as they relate to QC
- Develop and maintain Key Performance Indicators (KPIs) for laboratory testing
- Interface with vendors, suppliers, and in-house production personnel to ensure effective CAPAs are implemented for recurring product/process discrepancies.
- Delegate development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities
- Participate in and track group budget setting and cost containment drives
Required Qualifications :
- BS Science required, Masters preferred
- Minimum 7 years of experience in the pharmaceutical or biotech industry.
- QC laboratory, clinical laboratory, microbiology, or immunology experience in a CGMP/GTP environment.
- At least 5 years of management experience with the proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage staff performance.
- Sound understanding of current Good Manufacturing Practices (cGMPs)
- Knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation.
- Experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, and method validations.
- Able to develop strategic plans based on business needs
- Software proficiency in Microsoft Office and Visio.
- Excellent oral and written communication, collaborative, leadership, presentation, and influencing skills with strong business acumen, integrity, authenticity, and a growth mindset.
- Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers
- Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review
- Detail oriented with outstanding analytical and problem-solving abilities.
Contact: Allan Berman