QA Doc Control Supervisor Job at PCI Pharma Services
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
OB SUMMARY -
The QA Document Control Supervisor will have responsibility for the oversight of the Document Control team and processes. The supervisor sets priorities for the function, delegates responsibilities and balances workloads as needed, ensuring coverage at multiple locations. The supervisor leads and participates in daily document control tasks across multiple production facilities on multiple shifts, supporting continuity of service.
JOB DUTIES -
- Supervise QA personnel, including organizing and prioritizing group tasks, writing performance reviews and mentoring personnel in their longer-term development
- Responsible to ensure continuous document control support across multiple production facilities and multiple shifts
- Develop/implement/lead continuous process improvements for Document control, meeting timelines and providing clear and concise communication and updates to management. Lead, or delegate lead of projects.
- Responsible for the proper and timely issuance, maintenance and archiving of GMP controlled documentation / Batch Records / Controlled Forms, Logbooks, and other records
- Participate in daily document control tasks at multiple local facilities.
- May include:
- Facilitate Client Batch Record and other controlled document workflows in the QMS
- Leading workflows, Write and develop QA SOPs o Maintain Designated Satellite Areas for controlled paper distribution of procedures
- Issue Controlled Documents, executable records and maintains document archive
- Maintain paper and electronic Logs and databases
- Assist with tracking and trending metrics in support of Management Review
- Continuously promote collaborative work environment and cross-training across multiple production facilities
- Write / review / participate in Investigations related to Document Control activities
- Other duties as assigned
PROFESSIONAL SKILLS:
- Exceptional Organizational Skills and attention to detail
- Proficient to Advanced skills in MS Office
- Excellent Verbal and Written Communication Skills Required
- Works under minimal supervision following internal procedures and independent thinking
- Must have working knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory requirements
EXPERIENCE
- 2-3 years Supervisory experience
- 5+ years Document Control experiencePrevious experience with an electronic Quality Management System, MasterControl preferred
- 10 years relevant experience in a regulated industry
EDUCATION
- High School Diploma/associates degree
- Minimum of 10 years in a cGMP Environment;
- 5+ years previous experience with Bachelor's degree
QUALITIES
- Detail Oriented
- Strong multitasker who is comfortable working in a fast-paced environment
- Adaptable to changing work environment and shifting priorities · Team oriented and strong collaborative approach to work
PHYSICAL REQUIREMENTS
- Requires the ability to communicate effectively using speech, vision, hearing and written word
- Requires bending, squatting, climbing, reaching
- Requires the ability to lift, carry, push, or pull light weights (up to 20 pounds)
COMMUNICATIONS & CONTACTS
- Interacts with all departmental staff, and management
MANAGERIAL & SUPERVISORY RESPONSIBILITIES
- Supervision of 5+ direct reports across multiple sites
TRAVEL
- 10%-15%
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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.
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.
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