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QA/RA Manager

Westwood, MO | Permanent

Post Date: 06/05/2017 Job ID: BBBH23957_1496686743 Industry: Industrial Pay Rate: US$0.00 per year
FANTASTIC OPPORTUNITY FOR A TEMPORARY TO FULL TIME POSITION!

QA MANAGER



ESSENTIAL DUTIES:

Manages and maintains compliance with FDA Quality System Requirements, including company registration, new product submissions, and management of CAPA system. Assists with the development of product submissions for FDA and other major market regulatory agencies.

Conducts internal audits and coordinates and manage external ISO audit schedules, correspondence and closing of findings. Ensures compliance of labeling and advertising.

Participates as Company representative during agency investigations, audits, and inspections and prepares required responses and corrective action reports when necessary. Leads and trains the internal audit team to maintain compliance with stated quality policies and procedures.

Provides support to market-released products as necessary, including review of labeling, promotional materials, product/manufacturing process changes and related Quality System documentation changes requiring government approval.

Evaluates field reports, complaints, product returns and product analysis results to determine Medical Device Reporting (MDR) eligibility. Executes follow-up/investigation to assure all required elements are available for MDR review



MINIMUM QUALIFICATIONS:

Training and Experience. A Bachelor of Science degree in a related field, supplemented by at least seven years of relevant experience with 5 years in leadership role in a chemical manufacturing environment with demonstrated pattern of success. Prior experience participating and/or leading FDA audits.



Knowledge, Abilities and Skills

In depth knowledge of 21 CFR 210, 211, and 820. Specific knowledge of non-sterile OTC or Rx liquids. Understanding of classified manufacturing areas (i.E., Class 10, 000 per Fed STD 209E or ISO Class 7). Understanding of flow control, contamination control, industrial microbiology. Thorough knowledge of Good Manufacturing Practices. Strong knowledge of relevant regulatory guidance, including pharmaceutical current Good Manufacturing Practices (cGMPs), FDA, EPA and ISO. Strong knowledge of Lean Manufacturing disciplines and continuous improvements.



Ability to supervise a staff of quality and regulatory employees. Ability to communicate effectively, both verbally and in writing. Ability to read and understand published regulations. Ability to work effectively cross-functionally, influencing other key individuals outside of direct chain of command.

PHYSICAL REQUIREMENTS:

Must be able to stand for long periods of time occasionally.

If you are interested and meet all of the requirements, please submit your resume immediately

Allied Global Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Allied Global Services complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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