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Department:  Quality Operations

Shift:  Weekend B ( Fri, Sat, and Sun 7:00 pm-7 am)

Reporting To: Quality Operations Manager

Responsible For (Staff): Yes

Determines and maintains quality standards developed in compliance with current Good Manufacturing Practices, the Company's own Standard Operating Procedures, and customer requirements. Provides resolution to quality deviations/issues. Recommends solutions based on SOP / cGMP requirements.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Coordinates the daily activities of the QA Auditors.

Assists with the daily activities of Production Inspection personnel for packaging.

Implements inspection criteria and testing.

Study and standardize departmental work practices to improve the quality and efficiencies of subordinates.

Helps resolve quality-related issues with other departments and customers. Motivates, develops and provides continuous training either through the use of departmental work instructions, examination of cGMP's and SOP's, specific customer requirements or by personal instruction.

Review records for accuracy of information, compliance with established procedures.

Reviews daily paperwork to assure all customer requirements and quality standards have been met and maintained.

Promotes continuity of shifts through cooperation and communication within as well as with other departments.

Assist in the performance of monthly internal audits and any necessary corrective action to follow-up.

Oversees Pest Control and Environmental (humidity, temperature, MKT). Monitoring Programs May disposition NMR's.

Recommend and participate in disciplinary activities of subordinates.

Maintain testing equipment and supplies needed for the department.

May assist in performing investigations, may write reports, memos, or letters. This position may require overtime and/or weekend work.

Carries out essential functions of the Quality Operations Manager in his/her absence.

Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

Attendance to work is an essential function of this position.

Perform Quality Health Check assessments to identify if processes and day to day activities are performed according to procedures.

Performs other duties as assigned by Manager/Supervisor.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.

College Level Mathematical Skills

Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.

Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

High Standard of Report Writing

Preferred:

Ability to effectively present information to various people as the job requires.

Ability to work independently and/or as part of a team.

Ability to display a willingness to make decisions.

Ability to display excellent time management skills.

Equal Employment Opportunity/Veteran/
Disabled

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.