As one of the top contract pharmaceutical manufacturing and packaging companies in the U.S., Aphena Pharma Solutions serves the pharmaceutical industry sector, which includes the prescription pharmaceutical, OTC, dietary supplement, consumer health, medical device and biologics marketplaces.
With two FDA-registered locations in the U.S. — putting us logistically near at least 75% of the U.S. population — Aphena offers customers expansive capabilities and an array of turnkey services in the handling of solid dose, liquids, gels, creams, ointments, foams, suspensions, lotions, medical devices and biologic pharma products.Aphena Pharma Solutions is a medium business in Easton, MD. We are professional, agile and fast-paced.
Our work environment includes:
- Growth opportunities
- On-the-job training
- Safe work environment
The successful candidate for the position of Production Supervisor shall be fully capable of performing all essential and non-essential job functions listed in and possess all the qualifications itemized in sections 1.0 through 5.3.
1. Job Tasks
- 1.1 Utilize GMP standards to effectively manage production activities.
- 1.2 Schedule all assigned employees based on production needs.
- 1.3 Supervise all personnel that are assigned to shift/area.
- 1.4 Evaluate staffing requirements for the shift/area.
- 1.5 Challenge work centers to improve outputs and decrease labor.
- 1.6 Maintain efficient outputs and be able to anticipate problems that prevent efficient execution of production.
- 1.7 Evaluate current standards and procedures to improve efficiencies and eliminate waste.
- 1.8 Review and advise on changes in run rate and component usage at work centers.
- 1.9 Support line leads as required when necessary:
1.9.1 Prepare and execute MBRs
1.9.2 Perform sampling per QC requirements.
1.9.3 Initiate label requests and material requisitions
1.9.4 Perform work order confirmations and print pallet tickets.
1.9.5 Oversee line clearance, changeover and returns/counts.
- 1.10 Supervise and coordinate all employee training per documented instructions and maintain accurate training records.
- 1.11 Review and execute engineering, qualification and validation production runs. Maintain and review all documentation required and provide feedback and approvals.
- 1.12 Submit change controls as needed for work instruction, SOP, and MBR changes as needed.
- 1.13 Maintain current work center and facility documentation as required.
- 1.14 Ensure a clean and orderly work area is maintained to comply with 5S standards.
- 1.15 Work closely with the Quality Team to ensure product quality and adherence to GMP standards.
- 1.16 Assist with CAPA’s and NCR investigations as related to the shift/area.
- 1.17 Work closely with the Engineering/Maintenance department to implement lean processes improvement.
- 1.18 Work closely production planning and project management to ensure accurate scheduling of work centers to meet customer requirements. 1.19 Work closely with inventory management to ensure proper flow of materials and inventory discipline.
- 1.20 Evaluate staff, perform annual reviews.
- 1.21 Report any unsafe acts or accidents to the EHS Manager, Operations Manager and Human Resources.
- 1.22 Report/document any personnel issues to Human Resource and the Operations Manager.
- 1.23 Document disciplinary issues as they arise. Inform the Operations Manager and Human Resources of all disciplinary issues.
- 1.24 Work hours as needed to support the production schedule including overtime, which may be mandatory to maintain the production schedule/needs.
- 1.25 Train cross functionally as time permits.
- 1.26 Work closely with Operations Manager in all areas listed above.
- 2. Job Skills
- 2.1 Ability to analyze problems and present solutions
- 2.2 Ability to direct and supervise employees
- 2.3 Ability to be open-minded to all views and decisions
- 2.4 Knowledge of cGMP and ISO Regulations
- 2.5 Knowledge of FDA regulations.
- 2.6 Understanding of inventory control.
- 2.7 Proficient in basic math skills
- 2.8 Proficient in Mircosoft Word and Micrsoft Excel
- 2.9 Proficient in ERP and eQMS sytems
- 2.10 Good documentation practices including use of proper grammar and syntax.
- 3. Personal Attributes
- 3.1 Energetic
- 3.2 Works well with others.
- 3.3 Works well under pressure
- 3.4 Self starter 3.5 Trustworthy
- 3.6 Good personal hygiene
- 3.7 Dependable
- 3.8 Open minded
- 3.9 Detail oriented 3.10 Works well with very little supervision
- 3.11 Adaptable to change
- 4. Physical Requirements
- 4.1 Receive instructions through oral and written communications.
- 4.2 Convey answers or instructions to other employees.
- 4.3 Able to lift and move materials up to 40 pounds.
- 4.4 May be exposed to noise, chemicals, perfumes, fumes and odors.
- 4.5 Will be exposed to inside and outside environmental conditions.
- 4.6 The physical activity of this activity of this position includes, but is not limited to:
4.6.1 Climbing, walking, stooping, kneeling, crouching, reaching, standing, pushing, pulling, lifting, grasping, twisting, sitting, and feeling.
- 4.7 Safety equipment will be provided where needed and required to be worn.
- 5. Education/Experience
- 5.1 High school diploma required.
- 5.2 Completion of supervisory seminars/coursework a plus.
- 5.3 Three years of cGMP supervisory experience preferred.
Job Type: Full-time
Pay: $65,000.00 - $72,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Paid training
- Vision insurance
Experience level:
- 3 years
Shift:
- Night shift
Weekly day range:
- Monday to Friday
Shift availability:
- Overnight Shift (Required)
Work Location: In person