- Posted: 17 days ago
We are a global leader in the development and manufacturing of active pharmaceutical ingredients, focused on specialist niches with expertise in highly regulated and complex chemistries. Formerly part of Johnson Matthey, we have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle.Job Description
Manufacture of bulk API pharmaceuticals in accordance with customer and internal specifications.
- Completes batch records in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines
- Provide process support and troubleshooting necessary to meet all customer requirements
- Maintain the facility in excellent FDA/cGMP posture
- Responsible for safety equipment and active participation in safety program and hazard analysis
- Ensures that waste is appropriately characterized, labeled, stored and disposed in compliance with all Company, state and federal regulations. Works collaboratively with Environmental, Health & Safety, as appropriate.
- Assures all production/support equipment is in proper operating condition and that all production equipment is appropriately labeled with a current status tag. Works collaboratively with Maintenance, as appropriate.
- Ensures the security and safe handling of all controlled substances at all times. Strictly adheres to all Company and DEA regulations.
- Ensures a level of housekeeping appropriate for a pharmaceutical manufacturer and maintain 5S areas.
- Active member of Emergency Response Team. Participate in Emergency Response Training and related activities.
- Promotes a positive work environment by maintaining a safe work area and ensuring that their team members have the knowledge, skills and appropriate tools to perform their assigned duties and a thorough understanding of their performance expectations.
- Provides prompt, appropriate feedback to team members, both positive and constructive, in a continuing effort to develop employees to their full potential.
- Demonstrates a professional and positive attitude, integrity and a strong work ethic and encourages team members to do the same.
- Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department.
- Effectively communicates with QC Testing group regarding timing and prioritization of in-process sample requirements.
- Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers.
- Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated.
- Demonstrates technical proficiency and self-assuredness in applying cGMP standards.
- Applies cGMP concepts in association with department specific responsibilities.
- Ensures all documentation produced is in compliance with cGMP standards.
- Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies and customers, as needed.
- Walking, standing for long periods of time while in plant, reaching, handling, twisting, and bending spine at waist when operating equipment.
- Able to lift 50lbs
- High School Diploma with 5-7 years of experience in an API Manufacturing facility
- AA in Chemistry, Engineering, or other related technical field with 3-5 years of experience
- BS in Chemistry, Engineering or other related technical field
- Obtain and maintain certification as forklift operator
- Familiarity in 5S/Kaizen concepts
- Solid understanding of GMP and FDA
- Ability to independently apply scientific and/or technical knowledge in the performance of job duties
- Select key competencies required for this role
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state or local law.
All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.
AddressWest Deptford Township, NJ
ManufacturingView all jobs at Veranova
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