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SalaryPosition Summary:
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch, or crawl. vision abilities required by this job include close vision. Ability to lift up to 30 lbs.Knowledge and Skills:
Key Competencies
Additional Voluntary Benefits
The Manager, Product Inspection and Labeling is responsible for managing the Product Inspection and Labeling department of finished product for the 503b site. This role will ensure all inspection, labeling, and kitting processes adhere to cGMPs and company standards and SOPs.
Duties and Responsibilities: - Creates, implements, and manages the Product and Labeling team in executing daily work; assuring visual inspectors comply with company SOPs and policies, as well as provide positive feedback regarding work performance and adherence to cGMP regulations and industry standards.
- Manages multiple shifts and escalations during non-standard business hours.
- Maintains schedule adherence in accordance with production schedule and customer demand.
- Prepares and submits daily/weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities.
- Establishes and maintains cooperative cross-functional relationships with peers in Quality and other manufacturing operations to meet company objectives.
- Identifies and incorporates automation into area (semi-automatic or automatic inspection, labeling, kitting).
- Participates in equipment selection for designated area, assisting from design phase through training and implementation.
- Responsible for inspection program, batch records, encompassing SOPs, forms, work instructions.
- Responsible for the creation and maintenance of the exhibit vials and personnel qualification.
- Responsible for maintaining and monitoring trends for NCIs (non-conformance investigations) in respective area.
- Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions.
- Supports label printing activities and document review.
- Forecasts and sets goals and objectives, identifies and allocates resources as needed.
- Manages, trains, and develops front line leaders for efficient performance and assists in their career development.
- Creates an atmosphere of team effort and open communication.
- Supports regulatory inspections such as DEA and FDA audits.
- Develops training programs and assures training is conducted.
- Reports and initiates production schedule changes, requests equipment and facility repair or modifications.
- Performs other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch, or crawl. vision abilities required by this job include close vision. Ability to lift up to 30 lbs.
- Knowledge of current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOP), Food and Drug Administration (FDA) regulations, and other regulatory compliance regulations and standards
- Close attention to detail and accuracy.
- Proven analytical, problem solving and troubleshooting skills.
- Excellent organization, prioritization skills and the ability to multitask.
Key Competencies
- Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
- Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
- Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
- Resourcefulness: Secures and deploys resources effectively and efficiently.
- Manages Complexity: Makes sense of complex, high-quality, and sometimes contradictory information to effectively solve problems.
- Ensures Accountability: Holds self and others accountable to meet commitment.
- Situational Adaptability: Adapts approach and demeanor in real time to match the shifting demands of different situations.
- Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
- Bachelor’s Degree in Life Science or other related field preferred.
- Minimum 3-5 years prior experience in cGMP / FDA regulated industry for sterile injectables.
- 1 year of supervisory or management experience required.
- Registered with the Texas Board of Pharmacy as a Pharmacy Technician / National certification preferred.
- Current IV Certification preferred.
- No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
- Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
- Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
- Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
- Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
- Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
- Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
- FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
- 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
- Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
- Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
- Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck.
Additional Voluntary Benefits
- Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
- Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
- Critical Illness: Protect your finances from the expenses of a serious health issue.
- Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
- Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
- Legal Services: Access professional legal assistance to address concerns confidently.
- Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
- Pet Insurance: Care for your furry family members with our pet insurance coverage.
- Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.
