ACAD
26.02
-0.25
-0.95%
AEMD
1.874
+0.064
+3.5193%
APRI
0.95
-0.01
-1.04%
ARNA
1.31
-0.05
-3.68%
ATEC
1.99
-0.04
-1.97%
CNAT
5.17
-0.09
-1.71%
CRXM
0.161
-0.009
-5.4118%
CYTX
1.03
0.00
0.00%
DXCM
68.65
-0.5
-0.72%
GNMK
13.14
+0.14
+1.08%
HALO
12.41
-0.19
-1.51%
ILMN
175.91
+2.15
+1.24%
INNV
0.133
+0.015
+12.807%
INO
7.88
-0.11
-1.38%
ISCO
1.32
-0.17
-11.41%
ISIS
57.56
0.00
0.00%
LGND
110.19
-3.31
-2.92%
LPTN
2.93
-0.08
-2.66%
MBVX
1.66
-0.13
-7.26%
MEIP
2.12
+0.15
+7.61%
MNOV
5.95
-0.1
-1.65%
MRTX
3.25
-0.05
-1.52%
MSTX
0.131
-0.007
-5.278%
NBIX
46.22
-2.42
-4.99%
NUVA
75.52
-0.26
-0.34%
ONCS
1.06
+0.08
+8.16%
ONVO
2.94
+0.09
+3.16%
OREX
2.97
+0.03
+1.02%
OTIC
12.35
-0.3
-2.37%
QDEL
24.91
-0.01
-0.04%
RCPT
231.96
0.00
0.00%
RGLS
1.375
+0.025
+1.852%
RMD
70.07
+0.02
+0.03%
SCIE
0.001
+0.00
+16.6667%
SPHS
2.46
-0.01
-0.40%
SRNE
1.75
+0.1
+6.06%
TROV
0.651
-0.039
-5.6377%
VICL
2.36
0.00
0.00%
VOLC
18
0.00
0.00%
ZGNX
12.65
-0.25
-1.94%
ACAD
26.02
-0.25
-0.95%
AEMD
1.874
+0.064
+3.5193%
APRI
0.95
-0.01
-1.04%
ARNA
1.31
-0.05
-3.68%
ATEC
1.99
-0.04
-1.97%
CNAT
5.17
-0.09
-1.71%
CRXM
0.161
-0.009
-5.4118%
CYTX
1.03
0.00
0.00%
DXCM
68.65
-0.5
-0.72%
GNMK
13.14
+0.14
+1.08%
HALO
12.41
-0.19
-1.51%
ILMN
175.91
+2.15
+1.24%
INNV
0.133
+0.015
+12.807%
INO
7.88
-0.11
-1.38%
ISCO
1.32
-0.17
-11.41%
ISIS
57.56
0.00
0.00%
LGND
110.19
-3.31
-2.92%
LPTN
2.93
-0.08
-2.66%
MBVX
1.66
-0.13
-7.26%
MEIP
2.12
+0.15
+7.61%
MNOV
5.95
-0.1
-1.65%
MRTX
3.25
-0.05
-1.52%
MSTX
0.131
-0.007
-5.278%
NBIX
46.22
-2.42
-4.99%
NUVA
75.52
-0.26
-0.34%
ONCS
1.06
+0.08
+8.16%
ONVO
2.94
+0.09
+3.16%
OREX
2.97
+0.03
+1.02%
OTIC
12.35
-0.3
-2.37%
QDEL
24.91
-0.01
-0.04%
RCPT
231.96
0.00
0.00%
RGLS
1.375
+0.025
+1.852%
RMD
70.07
+0.02
+0.03%
SCIE
0.001
+0.00
+16.6667%
SPHS
2.46
-0.01
-0.40%
SRNE
1.75
+0.1
+6.06%
TROV
0.651
-0.039
-5.6377%
VICL
2.36
0.00
0.00%
VOLC
18
0.00
0.00%
ZGNX
12.65
-0.25
-1.94%
Home » Featured Jobs, San Diego Biotech Jobs

Document Control Specialist II

Submitted by on April 24, 2017 – 8:54 pm

Hiring Company: BioPhase Solutions Inc.

Location: San Diego, CA

Job Type: Quality Assurance

Description: BioPhase Solutions specializes in recruiting talented professionals for San Diego’s Scientific and Clinical Research community. We currently have an opening for a Sr. Document Control Associate with experience in the Biopharmaceutical industry.

SAN DIEGO CANDIDATES ONLY PLEASE!!!

RESPONSIBILITIES:
• Organize and ensure accurate and reliable filing systems for all paper-based GMP documents.
• Ensures all training is complete by all GXP personnel and up to date in the EDMS system.
• SME in managing and transferring paper based system to EDMS system document solutions for the organization (Master Control).
• Provides timely documentation for the organization and contract customers.
• Responsible for CGMP for maintenance of accurate and complete QMS records, standard operating procedures and other controlled documentation.
• Must clearly and frequently articulate and influence the “quality position” at the site.
• Input data for tracking quality metrics as required.
• Provide Communication on the document control system with direct manager, on a routine basis.
• Trains end users on EDMS/LMS Document Control Management application as needed.
• Responsible for assisting in PAI and other inspection readiness.
• Supports the development and management of quality metrics to optimize performance, productivity and effective resource planning.
• Responsible for off-site document archival and destruction per company policies.
• Participates in cross-functional project teams.
• Assist in Due Diligence activities.

REQUIREMENTS:
• Bachelor’s degree in a life science preferred with a minimum 5+ years of experience in a GXP document control position, and 5+ years of experience in archiving, inventory, maintaining and creating paper based systems and EDMS.
• Strong experience with Document Management in Master Control. Implementation and deployment of Master Control systems is highly desirable.
• Strong Document Control experience in support of FDA submissions/inspections. New Drug Application (NDA) is highly desirable.
• Excellent communication skills, with strong organizational, planning and follow-through, and computer skills. Ability to prioritize and multi-task independently.
• Ability to think analytically and attention to detail, exercise judgment within generally defined practices and policies in selecting methods and techniques to resolve complex problems positively and professionally.
• Demonstrated leadership skills and ability to interact with all levels of management in a multi-disciplinary team environment.
• Knowledge and understanding of ICH, CGMPS for Pharmaceuticals and Devices and relevant regulatory requirements.
• Quality-service attitude and willingness to work additional hours to meet deadlines.

Email address to send resume: shaun@biophaseinc.com

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