Supervisor, QA Documentation


Job ID 18-00007

Industry Pharma

Job Type Permanent

Location Somerset, NJ

Description

Supervisor, QA Documentation - 711BR
Security Clearance Required: No
Visa Candidate Considered: No
Full-time Benefits - Full
Relocation Assistance Available - No
Commission Compensation - No
Bonus Eligible - No
Overtime Eligible - No
Interview Travel Reimbursed - No

CANDIDATE DETAILS
2+ to 5 years' experience
Seniority Level - Mid-Senior
Management Experience Required - Yes
Minimum Education - Bachelor's Degree
Willingness to Travel – Never

SCREENING QUESTIONS
Do you know the "life cycle " of the Documentation Process?

IDEAL CANDIDATE
The ideal candidate must know the following:
Process Document Change Requests including the following:
Assign document numbers
Edit, prepare, process and distribute controlled documents
Retrieve obsolete SOPS
Prepare and maintain SOP index
Edit and maintain a Tracking Log for DCRs
Assign Document Change Request (DCR) tracking numbers
Ensure DCR's are circulated to appropriate reviewers for approval

SUMMARY:
This position serves as a dedicated resource for the administration of controlled documentation and documentation systems at the Company Somerset site. Associated documentation, systems and activities provide support for all facets of material, process and product development, validation, manufacture, testing, storage, service and distribution. It also applies to controlled documentation associated with employee training, facility/utility/equipment descriptions, calibration and maintenance, as well as associated documentation processing mechanisms (e.g. change control, archiving, storage, etc.)

ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.
Administer document control system.
Supervise daily activities of two document specialists
Issue batch production and control records to manufacturing after assuring that each record is a true copy of the Master Batch Record.
Process Document Change Requests including the following:
Assign document numbers
Edit, prepare, process and distribute controlled documents
Retrieve obsolete SOPS
Prepare and maintain SOP index
Edit and maintain a Tracking Log for DCRs
Assign Document Change Request (DCR) tracking numbers
Ensure DCR's are circulated to appropriate reviewers for approval
Maintain appropriate Tracking Logs and databases.
Provide documents and document change control data for change controls, annual product reviews, regulatory submissions and annual reports.
Provide information to the training group for the evaluation of required training for all employees relating to the Document System.

ADDITIONAL RESPONSIBILITIES:
Responsibilities include interviewing, hiring, training, planning, assigning and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.



Qualifications

QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND EXPERIENCE:
Bachelor's degree (BS) from four year college or university: plus at least two (2) years' experience in the pharmaceutical industry, in a documentation processing or related discipline.

JOB PREREQUISITES:
Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
Must be detail oriented.
Must have accomplished skills in computer-assisted documentation systems.
Must have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.
Must have a team work attitude.
Will interact with all functional departments within the company including hourly, professional and management personnel.