Job description

Role: Manufacturing Supervisor I

Location: Plainsboro, NJ 08536

Duration: 06 Months on W2

SUMMARY

The Production Supervisor is responsible for overseeing assigned manufacturing operations and related areas within the Collagen Manufacturing Center (CMC) facility. This role manages/coordinates resources,

maintains production schedule adherence, achieves production attainment goals, while operating under the guidance of Quality System Regulations (QSRs) and Good Manufacturing Practices (GMP).

SUPERVISION RECEIVED

Sr production Manager

SUPERVISION EXERCISED

• This position will supervise Manufacturing Cleanroom Operators and Lead Operators.

DISCRETION & LATITUDE

• The Production Supervisor is must demonstrate confidence in making good decisions and drive action.
• Must be able to escalate matters to his/her Supervisor and/or to the Human Resources CMC representative.
• Must be comfortable partnering and effectively work with other functional areas that support (directly or indirectly) the manufacturing operations.
• The Production Supervisor must manage and perform the work while guided by the Integra values and following company policies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Directs the daily production activities and personnel related to any of the following areas: Tendon, Dispersions, and/or Cleanroom Packaging. These areas are in class 7 and class 5 suites.
• Perform all work in compliance with Good Manufacturing Practices (Quality Systems Regulations), and Standard Operating Procedures, and Health and Safety requirements.
• Coach, counsel, train and motivate staff – provide clear direction and oversight of staff in effectively carrying out their daily responsibilities.
• Promote, train and support a safe work environment.
• Perform other related duties as expected.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

25% Manufacturing Execution:

• Ensure daily production schedule adherence and production attainment goals are met and report production line progress at shift meetings.
• Accurately maintain all entries into all required logs, log books and batch records.
• Operate, maintain, troubleshoot process equipment, and make minor adjustments as needed. Send plant alerts for situations that cannot be triaged or resolved.
• Interface with the Materials Management Department to ensure efficient flow of materials through operations.
• Works with Manufacturing Engineering and/or Product Development to validate/launch new products, improve production efficiency, improve product yields and reduce material scrap.

25% Quality & Regulatory Compliance:

• Support any Non-Conformance/CAPA/Audit related investigations.
• Initiate deviations and perform respective training.
• Maintain a clean and orderly work area, perform all work in compliance with Good
• Manufacturing Practices (Quality Systems Regulations), and Standard Operating Procedures, and Health and Safety requirements.
• Interface with QA/QC department during normal course of work to coordinate inspections of product.

Responsible for maintaining legible and accurate records and other procedures to comply with regulatory requirements, Good Manufacturing Practices (Quality Systems Regulations) and Standard Operating Procedures.

10% Fiscal Responsibilities:

• Responsible for completing all Oracle transactions during shift.
• Responsible for maintaining process and component inventories. Place Move Orders or Purchase Requisitions for general processing supplies.
• Interface with Finance for timely closure of workorders and materials issuance/transactions.
• Plan and lead manufacturing process improvements, and other Lean initiatives to optimize performance and drive short-term and long-term business improvements.

20% Performance Management:

• Coach and develop personnel.
• Cross-train personnel.
• Support and participate in cross-functional teams.
• Perform administrative duties (e.g. performance reviews, review/approve timecards, overtime, attendance, place purchase requisitions, maintain training records and curriculums, etc.).

20% Safety:

• Train all personnel on safety guidelines and regulations.
• Demonstrate safe behaviors, initiate safety reports when required, and support department/plant Safety goals in a continuous improvement process.

1 Total weighting should not exceed 100%

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• Education: Bachelor's degree in a relevant discipline or equivalent professional experience.
• Certifications: Lean Manufacturing certification (desired).
• Experience: Minimum 3 years of experience in the medical device or pharmaceutical industry in a supervisory role.

TOOLS AND EQUIPMENT USED

• The following general equipment list may be used for production activities: Tanks, vessels, pots, trays, temperature controllers, mechanical equipment, lyophilizers, homogenizers, coating machines, tornado mill, meat grinders, vacuum pumps, pH meters, thermometers/probes, agitators, balances, scales, water bath circulators, humidity cabinet, centrifuge, blenders, air gun, filamatic filling machines, meat slicers, drop indicator, scalpels, temperature recorders, crosslinking chamber, cutting table, packaging equipment (e.g. bar sealers, heat sealers, tray/cavity sealers, inline packaging, among others), and other area equipment.
• Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment.
• Strong computer skills are required.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility. Must be capable of using a keyboard for

computer purposes. In addition, this position must be able to:

• Independently travel via car or airplane to domestic and international locations as needed.
• Lift 30 to 60lbs.
• Stand for 8 hours
• Climb step ladder without assistance
• Use Personal Protective Equipment (PPE) when required

ADVERSE WORKING CONDITIONS

• The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.
• Daily interaction with hazardous materials used in a controlled environment.
• Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.

SELECTION GUIDELINES

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required

DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute and employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job

Job Type: Contract

Salary: Up to $30.00 per hour

Schedule:

• 8 hour shift
• Night shift

Education:

• Bachelor's (Required)

Experience:

• supervisory: 3 years (Required)
• Lean manufacturing: 3 years (Preferred)

Work Location: One location

Speak with the employer
+91 +17327193717

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