Quality Process

ARTURO A. MANUEL

Address: **** *. ******* ***., **. 220, Sta. Ana, CA 92707

Cell Phone #: 949-***-****, E-Mail: ******.**********@*****.***

WORK EXPERIENCES/Positions Held (BBraun Medical, Inc. (May, 1988 – December, 2012):

Manufacturing Lead, Duties and Responsibilities:

1) Directly responsible in overseeing the operations, manufacture of intravenous solutions and the work

assignments of over 80 hourly employees.

2) Train new employees on specific job functions, procedures, company policies, current Good

Manufacturing Practices (cGMP) and train all employees on new procedures.

3) Ensure that the company’s quantitative goals were met and manufacture of products is in compliance

to the company’s Quality standards, cGMP as well as FDA rules and regulations.

4) Consistently met and often exceeded production goals during tenure as Manufacturing Lead.

5) Review Production Records to ensure product compliance to cGMP, completeness, accuracy, product

specifications and quality standards were met.

6) Review, assess and evaluate employee's daily and annual performances.

7) Review, revise or create new procedures to ensure that manufacture of products is in compliance with

the company’s and FDA standards.

8) Numerous sections of the procedures were revised and new sections authored that became part of

the current procedures. As corrective action to non-conformance(s), compliance to product

specifications, cGMP and/or to improve the process.

Lead Associate Quality/Process Control, Duties and Responsibilities:

1) Monitor the operations and the manufacturing process of BBraun’s Production Lines to ensure

compliance to cGMP, product specifications, quality standards and FDA rules and regulations.

2) Perform product testing to ensure compliance to TIS (Tested Items Specifications), quality standards

and product acceptability.

3) Identify product defects, perform investigations when defect was determined and confirmed, generate

NLR (Non-Conforming Lot Report) OOS (Out-of-Specification) or Deviation Report.

4) Generate and coordinate NLR, OOS or Deviation corrective action with Production and Process

Control Techs. Generate reports after product corrective action to determine product releasability.

5) Provide training to QC Technicians on specific job functions, cGMP, company policies, procedures and

special product testing(s).

6) Direct work assignments of QC Techs to ensure Quality/Process Control support to Manufacturing.

7) Regularly review, assess and evaluate procedures to determine if change, changes or updates are

necessary. As corrective action to Non-conformance(s), OOS, Deviations, adherence to Quality

standards and/or to improve the process.

8) Numerous sections of the procedures were revised, new sections authored that became part of the

current procedures. As corrective action to non-conformances, compliance to product specifications

and/or to improve the process.

CHARACTER REFERENCES:

CATHERINE HO VICTORIA DISTOR

Supervisor, Quality/Process Control Supervisor, Quality/Process Control

BBraun Medical Inc. B Braun Medical, Inc.

2525 McGaw Ave., I rvine, CA 92614 2525 McGaw Ave., I rvine, CA 92614

Phone No.: 949-***-**** Phone No.: 949-***-****

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