This is a high-level management position. Full-Time with 40+ hours a week. Experience is preferred. Interested applicants at minimum must have at least a Bachelor's Degree, or equivalent experience. Preferred candidates will have experience in cGMP-regulated environments, overseeing production functions, and partnering with multiple areas of manufacturing.
SUMMARY: The Packaging Production Manager oversees daily packaging operations to ensure safe, efficient, and compliant production activities. This role is responsible for production scheduling, labor and resource management, batch execution, operational efficiency, and cross-functional coordination to support on-time product delivery and regulatory compliance.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
1. Compliance & Quality Assurance
- CGMP Adherence: Ensures compliance with approved Standard Operating Procedures (SOPs) and applicable regulatory requirements.
- Promptly identify issues, coordinate with QA, and report to superiors to obtain approval for necessary SOP revisions.
- Partners with QA to ensure compliance with quality systems and regulatory compliance.
- Deviation Management: In coordination with QA, investigates production nonconformances and generates nonconformance reports (NCRs), identifies root causes, and implements Corrective and Preventive Actions (CAPAs).
- Batch Records: Reviews and approves packaging records and protocols to ensure packaging documentation is accurate, complete, and ready for QA review and batch release activities.
- Manage and oversee the production environment (including associated warehouse areas) and comply with EHS (environment, health, and safety) guidelines.
2. Operations & Scheduling
- Production Planning: Coordinate with the Planning Department based on market demand and equipment capacity and execute packaging schedules.
- Throughput Optimization: Maximize line efficiency and minimize downtime.
- Resource Management: Estimates and manages labor, material, and equipment requirements to support production schedules.
- Ensures packaging components, tools, spare parts, and materials are available and properly controlled to support uninterrupted operations.
3. Equipment & Technology
- Ensure that the Packaging Technical Manager is able to maintain the packaging line machinery in a sustainable operational state, enabling consistent routine manufacturing processes.
- Promptly identify machinery issues and coordinate with Packaging Technical Manager and Engineering/Maintenance Department to resolve issues.
4. Team Leadership and Coordination
· Comply with all directives issued by superiors (specifically the Drug Product Division Management and/or the General Manager).
· Facilitate cross-departmental coordination, including personnel allocation, logistics arrangements, and warehousing operations.
· Coordinate activities across various production stages (e.g., product receipt, storage, visual inspection, labeling, assembly, packaging, finished product transfer, and rejected product/component disposition).
· Collaborate with the Packaging Administrative Manager to ensure that workforce is adequate to support packaging operations, thereby maintaining safe production practices with high standards of quality, accuracy, and efficiency.
SUPERVISORY RESPONSIBILITIES: Manages subordinate supervisors in the Packaging and Labeling departments. Is responsible for the overall direction, coordination, and evaluation of these units. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Compliance with governmental agencies is required.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE: Bachelor’s degree or equivalent; or eight to ten years related experience and/or training; or equivalent combination of education and experience.
LANGUAGE SKILLS: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees of the organization.
MATHEMATICAL SKILLS: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, volume, and efficiency.
REASONING ABILITY: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to talk or hear. The employee is occasionally required to stand; walk; sit; reach with hands and arms; and stoop, kneel, crouch, or crawl.
The employee must occasionally lift and/or move up to 25 pounds.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee frequently works near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles.
The noise level in the work environment is usually moderate.
Sunshine Act
Amphastar reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Amphastar to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Amphastar intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Amphastar that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.
EEO & Employment Eligibility
Amphastar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Amphastar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Amphastar is an E-Verify employer.
Amphastar is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Work Remotely
Job Type: Full-time
Pay: $95,000.00 - $140,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Education:
Work Location: In person
