Manufacturing Supervisor

Duration: 5+ Months

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.

% WEIGHTING OF

RESPONSIBILITY 1

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.

Shift: M-F 3rd shift position, hours 7:30pm - 4:30am.